Trial Outcomes & Findings for A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection (NCT NCT04585789)
NCT ID: NCT04585789
Last Updated: 2025-05-21
Results Overview
Absolute change from baseline to on-treatment liver biopsy timepoint (Week 40) in terms of the percentage of HBsAg-positive hepatocytes (at Week 40) were reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline, Week 40
Results posted on
2025-05-21
Participant Flow
Study consisted of 3 Panels (1, 2 and 3). Panel 1: participants with hepatitis B (HB) e antigen (HBeAg) positive and not treated. Panel 2: participants with HBeAg negative and virologically suppressed by entecavir (ETV), tenofovir disoproxil (TD), or tenofovir alafenamide (TAF) treatment. Panel 3: participants with HBeAg positive or negative who were either not treated or virologically suppressed by ETV or TD treatment.
As per protocol amendment (PA) 5 (dated 01 October 2021), all participants stopped JNJ-56136379 (JNJ-6379) treatment and continued treatment with JNJ-73763989 (JNJ-3989) plus nucleos(t)ide analog (NA; ETV, TD, or TAF) plus optional pegylated interferon alpha-2a (PegIFN-alpha2a). The study consisted of 3 phases: screening phase, open-label (OL) intervention phase and follow-up (FU) phase.
Participant milestones
| Measure |
Panel 1
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
Panel 3
After PA 5, participants received JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered follow-up and stopped JNJ-3989 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met based on Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
|---|---|---|---|
|
OL Phase: Week 1 to Week 48
STARTED
|
10
|
10
|
4
|
|
OL Phase: Week 1 to Week 48
COMPLETED
|
10
|
10
|
4
|
|
OL Phase: Week 1 to Week 48
NOT COMPLETED
|
0
|
0
|
0
|
|
FU Phase: Week 48 to Week 96
STARTED
|
10
|
10
|
4
|
|
FU Phase: Week 48 to Week 96
COMPLETED
|
8
|
10
|
4
|
|
FU Phase: Week 48 to Week 96
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Panel 1
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
Panel 3
After PA 5, participants received JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered follow-up and stopped JNJ-3989 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met based on Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
|---|---|---|---|
|
FU Phase: Week 48 to Week 96
Lost to Follow-up
|
1
|
0
|
0
|
|
FU Phase: Week 48 to Week 96
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
Baseline characteristics by cohort
| Measure |
Panel 1
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
Panel 3
n=4 Participants
After PA 5, participants received JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered follow-up and stopped JNJ-3989 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met based on Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 14.73 • n=5 Participants
|
43.4 years
STANDARD_DEVIATION 12.63 • n=7 Participants
|
42 years
STANDARD_DEVIATION 12.73 • n=5 Participants
|
39 years
STANDARD_DEVIATION 13.86 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
BELGIUM
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
CANADA
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
FRANCE
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
GERMANY
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
ITALY
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
NEW ZEALAND
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
POLAND
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
UNITED STATES
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 40Population: Intent-to-treat (ITT) population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Panels 1 and 2 alone.
Absolute change from baseline to on-treatment liver biopsy timepoint (Week 40) in terms of the percentage of HBsAg-positive hepatocytes (at Week 40) were reported.
Outcome measures
| Measure |
Panel 1
n=6 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=9 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1 and 2: Absolute Change From Baseline in the Percentage of Hepatitis B Surface Antigen (HBsAg) Hepatocytes at Week 40
|
-78.46 percentage of HBsAg hepatocytes
Interval -94.078 to -42.936
|
-5.68 percentage of HBsAg hepatocytes
Interval -15.846 to -0.885
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989)Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone.
Liver concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 - Molecules of JNJ-73763989 and JNJ-87719164 \[M65; deaminated metabolite of JNJ-73763976\]) at Week 12 were reported.
Outcome measures
| Measure |
Panel 1
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 12
JNJ-73763976
|
3550.00 nanograms per gram (ng/g)
Standard Deviation 1674.714
|
—
|
—
|
—
|
—
|
—
|
|
Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 12
JNJ-73763924
|
87300.00 nanograms per gram (ng/g)
Standard Deviation 31712.668
|
—
|
—
|
—
|
—
|
—
|
|
Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 12
M65
|
66175.00 nanograms per gram (ng/g)
Standard Deviation 26000.817
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989)Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone.
Liver concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 \[M65; deaminated metabolite of JNJ-73763976\]) at Week 40 were reported.
Outcome measures
| Measure |
Panel 1
n=3 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 40
JNJ-73763976
|
5883.33 ng/g
Standard Deviation 2147.145
|
—
|
—
|
—
|
—
|
—
|
|
Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 40
JNJ-73763924
|
208666.67 ng/g
Standard Deviation 66860.551
|
—
|
—
|
—
|
—
|
—
|
|
Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 40
M65
|
133800.00 ng/g
Standard Deviation 50615.413
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989)Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone.
Plasma concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924-molecules of JNJ-73763989) at Week 12 were reported.
Outcome measures
| Measure |
Panel 1
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 3: Plasma Concentration of JNJ-73763989 (JNJ-73763976, and JNJ-73763924) at Week 12
JNJ-73763976
|
254.70 nanograms per milliliters (ng/mL)
Standard Deviation 123.841
|
—
|
—
|
—
|
—
|
—
|
|
Panel 3: Plasma Concentration of JNJ-73763989 (JNJ-73763976, and JNJ-73763924) at Week 12
JNJ-73763924
|
36.18 nanograms per milliliters (ng/mL)
Standard Deviation 22.667
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989)Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure (OM) was planned to be collected and analyzed for Panel 3 alone.
Plasma concentrations of JNJ-73763989 (JNJ-73763976 and JNJ-73763924-molecules of JNJ-73763989) at Week 40 were reported.
Outcome measures
| Measure |
Panel 1
n=3 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 3: Plasma Concentrations of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) at Week 40
JNJ-73763976
|
530.97 ng/mL
Standard Deviation 176.408
|
—
|
—
|
—
|
—
|
—
|
|
Panel 3: Plasma Concentrations of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) at Week 40
JNJ-73763924
|
74.87 ng/mL
Standard Deviation 12.788
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989)Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone.
Correlation of liver concentration to plasma concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and liver concentration of JNJ-87719164 (M65: Deaminated metabolite of JNJ-73763976) to liver concentration JNJ-73763976 at Week 12 were reported.
Outcome measures
| Measure |
Panel 1
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 3: Correlation of Liver Concentration to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 12
JNJ-73763976 (liver to plasma concentration)
|
14.51 ratio
Standard Deviation 4.725
|
—
|
—
|
—
|
—
|
—
|
|
Panel 3: Correlation of Liver Concentration to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 12
JNJ-73763924 (liver to plasma concentration)
|
2844.26 ratio
Standard Deviation 1265.202
|
—
|
—
|
—
|
—
|
—
|
|
Panel 3: Correlation of Liver Concentration to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 12
M65 to JNJ-73763976 (liver to liver concentration)
|
19.47 ratio
Standard Deviation 3.267
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989)Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone.
Correlation of liver concentration to plasma concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and liver concentration of JNJ-87719164 (M65: Deaminated metabolite of JNJ-73763976) to liver concentration JNJ-73763976 at Week 40 were reported.
Outcome measures
| Measure |
Panel 1
n=3 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 3: Correlation of Liver to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 40
JNJ-73763976 (liver to plasma concentration)
|
12.67 ratio
Standard Deviation 7.269
|
—
|
—
|
—
|
—
|
—
|
|
Panel 3: Correlation of Liver to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 40
JNJ-73763924 (liver to plasma concentration)
|
2847.66 ratio
Standard Deviation 1034.033
|
—
|
—
|
—
|
—
|
—
|
|
Panel 3: Correlation of Liver to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 40
M65 to JNJ-73763976 (liver to liver concentration)
|
22.65 ratio
Standard Deviation 1.407
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Follow-up Week 48Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this OM.
Percentage of participants with sustained (reduction) serum HBsAg response per Definition 2 at follow-up Week 48 were reported. Sustained serum HBsAg response per definition 2 was defined as: for participants with a \>1 log decline in HBsAg from baseline at last follow up visit: Among the most recent three visits, the difference between log HBsAg at 2 of 3 last visit and 1 of 3 last visit is \<0.2, and the difference between log HBsAg at 3 of 3 last visit and 1 of 3 last visit is \<0.2.
Outcome measures
| Measure |
Panel 1
n=8 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=7 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=2 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 2 at Follow-up Week 48
|
50.0 Percentage of participants
Interval 23.97 to 76.03
|
42.9 Percentage of participants
Interval 16.96 to 72.14
|
50.0 Percentage of participants
Interval 5.13 to 94.87
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Follow-up Week 48Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Percentage of Participants who achieved HBsAg Seroclearance were reported. HBsAg seroclearance was defined as quantitative HBsAg \<LLOQ (\<0.05 IU/mL).
Outcome measures
| Measure |
Panel 1
n=8 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants Who Achieved HBsAg Seroclearance
|
25.0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Follow-up Week 48Population: ITT population: participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. "N"(Number of participants analyzed) = number of participants evaluable for this outcome measure. Data was not collected for Panel 2 participants as they were HBeAg negative at enrollment and thus did not fulfill planned analysis criteria (HBeAg positive status).
Percentage of Participants who achieved HBeAg Seroclearance were reported. HBeAg seroclearance was defined as (quantitative\] HBeAg \<LLOQ (\<0.11 IU/mL); with HBeAg positive status at baseline and became HBeAg negative post-baseline.
Outcome measures
| Measure |
Panel 1
n=8 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=2 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants Who Achieved HBeAg Seroclearance
|
37.5 percentage of participants
|
—
|
50.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this OM was not planned to be collected and analyzed for Panel 3.
Change from baseline in percentage of intrahepatic viral parameter: HBcAg positive hepatocytes at Week 40 were reported. The percentage of HBcAg positive hepatocytes were derived as number of HBcAg positive hepatocytes\*100 per total number of evaluated hepatocytes.
Outcome measures
| Measure |
Panel 1
n=6 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=9 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1 and 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: Hepatitis B Core Antigen Positive (HBcAg+) Hepatocytes at Week 40
|
-54.49 percent change in HBcAg+ Hepatocytes
Interval -87.02 to -42.26
|
0.03 percent change in HBcAg+ Hepatocytes
Interval 0.0 to 0.04
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Panel 3.
Change from baseline in percentage of intrahepatic viral parameter: cccDNA positive hepatocytes were reported. The percentage of cccDNA-positive hepatocytes, were derived as number of cccDNA positive hepatocytes\*100 per total number of evaluated hepatocytes.
Outcome measures
| Measure |
Panel 1
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1,and 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: Covalently Closed Circular Deoxyribonucleic Acid Positive (cccDNA+) Hepatocytes at Week 40
|
-4.50 percent change in cccDNA+ hepatocytes
Interval -40.88 to 12.97
|
-2.40 percent change in cccDNA+ hepatocytes
Interval -22.84 to 7.57
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm andreceived at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Panel 3.
Change from baseline in percentage of intrahepatic viral parameter: HBsAg positive hepatocytes at Week 40 were reported. The percentage of HBsAg positive hepatocytes were derived as number of HBsAg positive hepatocytes \* 100 per total number of evaluated hepatocytes.
Outcome measures
| Measure |
Panel 1
n=6 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=9 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1 and 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: HBsAg Positive (HBsAg+) Hepatocytes at Week 40
|
-92.38 percent change in HBsAg+ hepatocytes
Interval -95.65 to -73.37
|
-14.19 percent change in HBsAg+ hepatocytes
Interval -21.11 to -7.01
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this OM was not planned to be collected and analyzed for Panel 3.
Change from baseline in percentage of intrahepatic viral Parameter: pgRNA positive hepatocytes at Week 40 were reported. The percentage of pgRNA-positive hepatocytes, were derived as number of pgRNA positive hepatocytes\*100 per total number of evaluated hepatocytes.
Outcome measures
| Measure |
Panel 1
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1 and 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: Pre-genomic Ribonucleic Acid Positive (pgRNA+) Hepatocytes at Week 40
|
-81.23 percent change in pgRNA+ hepatocytes
Interval -86.19 to -74.14
|
-6.74 percent change in pgRNA+ hepatocytes
Interval -15.81 to -2.01
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Panel 3.
Change from baseline in transcriptional activity (ratio of pgRNA/cccDNA) at Week 40 were reported.
Outcome measures
| Measure |
Panel 1
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1 and 2: Change From Baseline in Transcriptional Activity (Ratio of pg RNA/cccDNA) at Week 40
|
50.00 ratio
Interval 49.07 to 58.83
|
8.86 ratio
Interval -3.03 to 27.45
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Panel 3.
Change from baseline in percentage of intrahepatic viral parameter: silent infected hepatocytes (that is infected hepatocytes without HBV transcription; cccDNA-positive/HBV RNA-negative hepatocytes) at Week 40 were reported. The percentage of silent infected hepatocytes (SIH), were derived as number of silent infected hepatocytes\*100 per total number of evaluated hepatocytes.
Outcome measures
| Measure |
Panel 1
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2: Change From Baseline in Percentage of Intrahepatic Viral Parameter: Silent Infected Hepatocytes at Week 40
|
25.06 percent change in SIH
Interval 21.4 to 31.63
|
2.88 percent change in SIH
Interval -14.74 to 8.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 72 (24 weeks after completion of all study drugs at Week 48)Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Percentage of participants with HBsAg seroclearance (defined as HBsAg \< LLOQ: 0.05 IU/mL) at Week 72 without restarting NA treatment were reported.
Outcome measures
| Measure |
Panel 1
n=9 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants With HBsAg Seroclearance at Week 72 Without Restarting Nucleos(t)Ide Analog (NA) Treatment
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Follow-up Week 48Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled.
Percentage of participants with sustained (reduction) serum HBsAg response per Definition 1 at follow-up Week 48 were reported. Sustained serum HBsAg response per definition 1 was defined as: for participants with data for last follow-up visit (Follow-up Week 48 for participants who did not receive PegIFN-alpha2a or received PegIFN-alpha2a and did not meet NA completion criteria, and last Follow-up visit for participants who received PegIFN-alpha2a and stopped NA during Follow-up): participants who had a \>1 log decline in HBsAg response at last scheduled follow-up visit and had an HBsAg \<1000 IU/mL at last scheduled follow-up visit, or for participants without data at last follow-up visit: HBsAg values had a \>2 log decline at second most recent visit or \>1.5 log decline at latest visit (most recent value used) compared to baseline and had an HBsAg \<1000 IU/mL at last available timepoint.
Outcome measures
| Measure |
Panel 1
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 1 at Follow-up Week 48
|
50.0 Percentage of participants
Interval 26.73 to 73.27
|
70.0 Percentage of participants
Interval 44.83 to 88.42
|
50.0 Percentage of participants
Interval 14.26 to 85.74
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From follow-up Week 24 up to follow-up Week 48Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Percentage of participants with sustained (reduction) serum HBsAg response per Definition 3 at follow-up Week 48 were reported. Sustained serum HBsAg response per definition 3 for participants with a \>1 log decline in HBsAg from baseline at last follow up visit: Among the most recent three visits, the difference between log HBsAg at 2 of 3 last visit and 1 of 3 last visit is \<0.2, and the difference between log HBsAg at 3 of 3 last visit and 1 of 3 last visit is \<0.2 and have an HBsAg \<1000 IU/mL at the last available timepoint.
Outcome measures
| Measure |
Panel 1
n=8 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=7 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=2 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 3 at Follow-up Week 48
|
25.0 Percentage of participants
Interval 6.86 to 53.82
|
42.9 Percentage of participants
Interval 16.96 to 72.14
|
50.0 Percentage of participants
Interval 5.13 to 94.87
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Follow-up Week 48Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
Percentage of participants with sustained (reduction) serum HBsAg response per definition 4 follow-up Week 48 were reported. Sustained serum HBsAg response per definition 4 were classified into 3 categories with respect to the difference between HBsAg level at the last Follow-up timepoint and end of treatment: Increase: \>+0.2 log10 IU/mL , stable: within plus or minus (+/-) 0.2 log10 IU/mL, and decrease: \>-0.2 log10 IU/mL.
Outcome measures
| Measure |
Panel 1
n=9 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 4 at Follow-up Week 48
Stable: Within +/-0.2 log10
|
11.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 4 at Follow-up Week 48
Decrease: > -0.2 log10 IU/mL
|
22.2 Percentage of participants
|
30.0 Percentage of participants
|
25.0 Percentage of participants
|
—
|
—
|
—
|
|
Panel 1, 2 and 3: Percentage of Participants With Sustained (Reduction) Serum HBsAg Response Per Definition 4 at Follow-up Week 48
Increase: > +0.2 log10 IU/mL
|
66.7 Percentage of participants
|
70.0 Percentage of participants
|
75.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (Day 1) up to follow-up Week 48Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance (defined as quantitative HBsAg \<LLOQ \[\<0.05 IU/mL\]) and appearance of anti-HBs antibodies (defined as a baseline anti-HBs antibodies \[quantitative\] \<LLOQ \[\<5 milli-international units per milliliter {mIU/mL}\] and a post-baseline assessment \>=LLOQ \[\>=5 mIU/mL\]).
Outcome measures
| Measure |
Panel 1
n=7 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=9 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants Who Achieved HBsAg Seroconversion
|
28.6 Percentage of participants
|
11.1 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (Day 1) up to follow-up Week 48Population: ITT population: participants randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. "N' (number of participants analyzed) = participants evaluable for this outcome measure. Data was not collected for Panel 2 participants as they were HBeAg negative at enrollment and thus did not fulfill planned analysis criteria (HBeAg positive status).
Percentage of participants who achieved HBeAg seroconversion were reported. Seroconversion of HBeAg was defined as having achieved HBeAg seroclearance (defined as \[quantitative\] HBeAg \<LLOQ \[\<0.11 IU/mL\]; with HBeAg positive status at baseline and became HBeAg negative post-baseline) together with appearance of anti-HBe antibodies (defined as a baseline anti-HBe antibodies \[qualitative\] with a "negative" result and a post-baseline assessment with "positive" result).
Outcome measures
| Measure |
Panel 1
n=7 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=2 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants Who Achieved HBeAg Seroconversion
|
28.6 Percentage of participants
|
—
|
50.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (Day 1) up to follow-up Week 48Population: ITT population: participants randomly assigned or enrolled to an intervention arm and received at least 1 dose of drug. Participants were analyzed according to study drug randomly assigned/enrolled. "N" (Number of participants analyzed) = participants evaluable for this outcome measure. Data was not collected for Panel 1, as no participants met off-treatment criteria (set duration between last dose and last study visit) at final analysis and thus were not considered eligible for analysis.
Virologic flare (VF) per derivation 1 was defined only for participants who were off-treatment (period after stopping all study drugs, including NA) and who had HBV DNA\<LLOQ (\<20 IU/mL) at last observed point on-treatment \[OT\]); start date of confirmed VF was first date of 2 consecutive visits with HBV DNA \>200 IU/mL. End date of same confirmed VF was first date when HBV DNA value returns to \<=200 IU/mL or date of NA restart, whichever comes first. Each virologic flare were categorized based on confirmed (that is, 2 consecutive values) peak HBV DNA above any of 3 thresholds within the start and end date of that flare as followed: 20,000 IU/mL, 2,000 IU/mL, and 200 IU/mL. Participants were counted only once for any given flare, regardless of the number of times they actually experienced the flare.
Outcome measures
| Measure |
Panel 1
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=3 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=2 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants With Off-treatment Virologic Flares Per Derivation 1
HBV DNA > 200 IU/mL
|
—
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Panel 1, 2 and 3: Percentage of Participants With Off-treatment Virologic Flares Per Derivation 1
HBV DNA > 2,000 IU/mL
|
—
|
33.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Panel 1, 2 and 3: Percentage of Participants With Off-treatment Virologic Flares Per Derivation 1
HBV DNA > 20,000 IU/mL
|
—
|
0 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (Day 1) up to follow-up Week 48Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here, "n"(number analyzed) signifies number of participants analyzed at specified categories and n=0 signifies that no participant was available for the analysis at the specified category.
Off-treatment (time period after stopping all study drugs \[including NA\]) biochemical flare was defined as first date of 2 consecutive visits with ALT and/or AST \>=3\*ULN and \>=3\*nadir (lowest value observed up to start of flare) while participant received no study drugs. End date of same off-treatment biochemical flare was defined as first date with 50 percentage (%) reduction from peak ALT and/or AST level \& \<3\*ULN. On-treatment (time period during which the participant received any of study drugs) biochemical flare was defined as first date of 2 consecutive visits with ALT and/or AST \>=3\*ULN and \>=3\*nadir (lowest value observed up to start of flare) while participant was on-treatment. End date of same on-treatment biochemical flare was defined as first date with a 50% reduction from the peak ALT and/or AST level and \<3\*ULN, regardless of stopping study drugs. Participants were counted only once for any given flare, regardless of the number of times they actually experienced flare.
Outcome measures
| Measure |
Panel 1
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants With Off-treatment and On-treatment Biochemical Flares
Off-treatment biochemical flare
|
—
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Panel 1, 2 and 3: Percentage of Participants With Off-treatment and On-treatment Biochemical Flares
On-treatment biochemical flare
|
10.0 percentage of participants
|
10.0 percentage of participants
|
25.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (Day 1) up to follow-up Week 48Population: ITT population: participants randomly assigned/enrolled to an intervention arm and received at least 1 dose of drug. Participants were analyzed according to study drug randomly assigned/enrolled. "N" (Number of participants analyzed) = participants evaluable for this outcome measure. Data was not collected for Panel 1, as no participants met off-treatment criteria (set duration between last dose and last study visit) at final analysis and thus were not considered eligible for analysis.
Percentage of participants with off-treatment clinical flares were reported. Clinical flares occurred either when a virologic flare and biochemical flare overlapped in time or when a biochemical flare started within 4 weeks following the end of a virologic flare. Off-treatment was defined as the time period after stopping all study drugs (including NA). The start date of a clinical flare was the minimum start date of the virologic flare and biochemical flare. The end date of a clinical flare was the maximum end date of the virologic flare and biochemical flare, that is, the later date between HBV DNA returned to \<=200 IU/mL (or \<=1 log10) and 50 %reduction from the peak ALT and/or AST level and \<3\*ULN reached during the biochemical flare. Participants were counted only once for any given flare, regardless of the number of times they actually experienced the flare.
Outcome measures
| Measure |
Panel 1
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=3 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=2 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants With Off-treatment Clinical Flares
HBV DNA >200 IU/mL
|
—
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Panel 1, 2 and 3: Percentage of Participants With Off-treatment Clinical Flares
HBV DNA >2,000 IU/mL
|
—
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Panel 1, 2 and 3: Percentage of Participants With Off-treatment Clinical Flares
HBV DNA >20,000 IU/mL
|
—
|
0 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (Day 1) up to follow-up Week 48Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled.
Time to first occurrence of HBsAg seroclearance (defined as quantitative HBsAg \<LLOQ \[\<0.05 IU/mL\]) were reported. Time to first occurrence of HBsAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBsAg seroclearance. Participants who withdrew early from the study before achieving HBsAg seroclearance or who did not achieve HBsAg seroclearance were censored at the last available HBsAg assessment. Kaplan-Meier method was used for the estimation.
Outcome measures
| Measure |
Panel 1
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Time to First Occurence of HBsAg Seroclearance
|
NA weeks
NA indicates that median and 80% CI data were not estimable due to insufficient number of participants with events.
|
NA weeks
NA indicates that median and 80% CI data were not estimable due to insufficient number of participants with events.
|
NA weeks
NA indicates that median and 80% CI data were not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (Day 1) up to follow-up Week 48Population: ITT population included participants who were randomly assigned or enrolled to an intervention arm and received at least 1 dose of intervention. Participants were analyzed according to study intervention they were randomly assigned or enrolled.
Percentage of participants with virologic breakthrough on treatment were reported. Virological breakthrough was defined as having a confirmed on-treatment HBV DNA increase by \>1 log10 IU/mL from nadir level (lowest level reached during treatment) in participants who did not have on-treatment HBV DNA level \< LLOQ (\<20 IU/mL) or confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had on-treatment HBV DNA level \<LLOQ (\<20 IU/mL) of the HBV DNA assay. Confirmed HBV DNA increase/level means that the criterion should be fulfilled at 2 or more consecutive time points or at the last observed on-treatment time point. On treatment was defined as the time period in which the participant received any of the study interventions (JNJ-3989 and/or JNJ 6379 and/or NA and/or PegIFN-alpha2a).
Outcome measures
| Measure |
Panel 1
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants With Virologic Breakthrough
|
0 percentage of participants
Interval 0.0 to 20.57
|
0 percentage of participants
Interval 0.0 to 20.57
|
0 percentage of participants
Interval 0.0 to 43.77
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Open-label: Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Percentage of participants with TEAES (including serious and non-serious) and TESAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Panel 1
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
n=10 Participants
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
n=10 Participants
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
90.0 percentage of participants
|
100.0 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
60.0 percentage of participants
|
75.0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAEs
|
10.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Open-label: Weeks 40, 44, and 48; Follow-up Phase: Follow-up Weeks 2, 12 and 24Population: ITT population were analyzed. Participants were analyzed according to study intervention they were randomly assigned or enrolled. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n"(number analyzed) signifies number of participants analyzed at specified categories. Here, n=0, signifies that no participants were available for the analysis.
Number of participants with HBV-specific peripheral blood T-cell responses were reported. HBV-specific T-cells were characterized in peripheral blood mononuclear cell immune analysis by binding assays (multimer staining) combined with downstream T-cell responses and transcriptome profiling.
Outcome measures
| Measure |
Panel 1
n=7 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=7 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=1 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
n=9 Participants
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
n=10 Participants
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Number of Participants With HBV-Specific Peripheral Blood T-cell Responses
Open Label: Week 40
|
6 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Panel 1, 2 and 3: Number of Participants With HBV-Specific Peripheral Blood T-cell Responses
Open Label: Week 44
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Panel 1, 2 and 3: Number of Participants With HBV-Specific Peripheral Blood T-cell Responses
Open Label: Week 48
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Panel 1, 2 and 3: Number of Participants With HBV-Specific Peripheral Blood T-cell Responses
Follow-up Week 2
|
—
|
—
|
—
|
4 Participants
|
10 Participants
|
3 Participants
|
|
Panel 1, 2 and 3: Number of Participants With HBV-Specific Peripheral Blood T-cell Responses
Follow-up Week 12
|
—
|
—
|
—
|
1 Participants
|
5 Participants
|
2 Participants
|
|
Panel 1, 2 and 3: Number of Participants With HBV-Specific Peripheral Blood T-cell Responses
Follow-up Week 24
|
—
|
—
|
—
|
5 Participants
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Open-label: Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here "n" (number analyzed) signifies number of participants analyzed at specified categories.
Clinical laboratory test parameters were Hematology : absolute neutrophil count (ANC); Chemistry : alanine aminotransferase (ALT) and serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase(AST) or serum glutamic oxaloacetic transaminase (SGOT), amylase (pancreatic and total), creatinine Kinase, creatinine, low-density lipoprotein (LDL), lipase, estimated glomerular filtration rate (eGFR) on serum creatinine (Cr). DAIDS toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). Percentage of participants with treatment-emergent DAIDS toxicity Grade 3 or 4 were reported in this outcome measure. For toxicity grades, treatment-emergent was concluded if the postbaseline grade was worse than the baseline grade. Only those abnormality categories in which at least one participant had data were reported.
Outcome measures
| Measure |
Panel 1
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
n=10 Participants
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
n=10 Participants
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Grade 3 and 4) Treatment-emergent Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grade in Clinical Laboratory Tests
Hematology: Absolute Neutrophil Count: Low: Grade 3
|
0 percentage of participants
|
10.0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
10.0 percentage of participants
|
25.0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Grade 3 and 4) Treatment-emergent Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grade in Clinical Laboratory Tests
Chemistry: ALT or SGPT: High: Grade 3
|
0 percentage of participants
|
10.0 percentage of participants
|
25.0 percentage of participants
|
10.0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Grade 3 and 4) Treatment-emergent Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grade in Clinical Laboratory Tests
Chemistry: ALT or SGPT: High: Grade 4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Grade 3 and 4) Treatment-emergent Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grade in Clinical Laboratory Tests
Chemistry: AST/SGOT: High: Grade 3
|
0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Grade 3 and 4) Treatment-emergent Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grade in Clinical Laboratory Tests
Chemistry: Amylase (Pancreatic): High: Grade 4
|
25.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Grade 3 and 4) Treatment-emergent Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grade in Clinical Laboratory Tests
Chemistry: Amylase (Total): High: Grade 3
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Grade 3 and 4) Treatment-emergent Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grade in Clinical Laboratory Tests
Chemistry: Creatinine Kinase : High: Grade 3
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Grade 3 and 4) Treatment-emergent Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grade in Clinical Laboratory Tests
Chemistry: Creatinine Kinase : High: Grade 4
|
0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Grade 3 and 4) Treatment-emergent Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grade in Clinical Laboratory Tests
Chemistry: Creatinine: High: Grade 3
|
11.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Grade 3 and 4) Treatment-emergent Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grade in Clinical Laboratory Tests
Chemistry: LDL (Fasting): High: Grade 3
|
0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Grade 3 and 4) Treatment-emergent Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grade in Clinical Laboratory Tests
Chemistry: Lipase: High: Grade 3
|
0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Grade 3 and 4) Treatment-emergent Division of Acquired Immunodeficiency Syndrome (DAIDS) Toxicity Grade in Clinical Laboratory Tests
Chemistry: eGFR Cr: Low: Grade 3
|
0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Open-label: Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
ECG parameters included ECG mean heart rate (HR)(beats per minute\[bpm\]), Pulse rate (PR) interval (milliseconds \[ms\]), QRS duration (ms) and QTc Corrected (Fridericia's formula QTcF). Abnormalities were graded as follows: ECG mean heart rate (abnormally low HR \<45 bpm) and (abnormally high HR\>=120 bpm); PR interval (abnormally high \>220 ms) and QPRS (abnormally high \>=120 ms); OT interval corrected for heart rate according to Fridericia (QTcF); borderline prolonged (BRD Pr )QTc (\>=450 to \<=480 ms), prolonged QTc (\>=480 to \<=500 ms)and pathologically prolonged QTc (\>500 ms). For worst abnormality, treatment-emergent was concluded if the abnormality worsened as compared to the abnormality at baseline: abnormally high to abnormally low and vice-versa. Only those abnormality categories in which at least one participant had data were reported.
Outcome measures
| Measure |
Panel 1
n=9 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
n=9 Participants
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
n=10 Participants
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Abnormally Low/High)Treatment-emergent DAIDS Toxicity Grade in Electrocardiogram (ECG)
ECG Mean HR: low (<45 bpm)
|
0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Abnormally Low/High)Treatment-emergent DAIDS Toxicity Grade in Electrocardiogram (ECG)
PR Interval: Aggregate: Abnormally high (>220 ms)
|
11.1 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
11.1 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Abnormally Low/High)Treatment-emergent DAIDS Toxicity Grade in Electrocardiogram (ECG)
QTcF Interval: Aggregate: borderline prolonged QT (>=450to<=480 ms)
|
0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Open-label: Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here "N" (Number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Percentage of participants with worst treatment-emergent DAIDS toxicity grade in vital signs were reported. Abnormality grades were: pulse rate (abnormally low \<=45 bpm) and (abnormally high \>=120 bpm). An assessment was treatment-emergent if abnormality worsened as compared to the abnormality at baseline: from abnormally high to abnormally low and vice-versa. Only the category (pulse rate) in which at least one participant had data were reported.
Outcome measures
| Measure |
Panel 1
n=9 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
n=10 Participants
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
n=10 Participants
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Percentage of Participants With Worst (Abnormally Low/High) Treatment-emergent DAIDS Toxicity Grade in Vital Signs
|
0 percentage of participants
|
10.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Open-label: Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Number of participants with clinically significant treatment-emergent abnormalities in physical examination were reported. Physical examination included head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological examinations.
Outcome measures
| Measure |
Panel 1
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=10 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
n=10 Participants
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
n=10 Participants
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
n=4 Participants
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 1, 2 and 3: Number of Participants With Clinically Significant Treatment-emergent Abnormalities in Physical Examination
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4 : Pre-dose on Day 29Population: A pharmacokinetics (PK) analysis which included participants of Panel 2 and Panel 3 who had consented to participate in the intensive PK subgroup were analyzed. Data for this outcome measure was planned to be collected and analyzed for Panel 2 and 3 alone.
Plasma trough concentration (C\[0hour\]) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. C0h was the pre-dose plasma concentration of the JNJ-73763989 (JNJ-73763976, JNJ-73763924). Non-compartmental analysis were conducted to analyze plasma concentration of JNJ-73763989 and its molecules.
Outcome measures
| Measure |
Panel 1
n=3 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 2 and 3: Plasma Trough Concentration (C[0hour]) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763976
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
NA signifies that mean and standard deviation were not calculable because sample concentration was below quantification limit (that is \<2.1 ng/mL).
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
NA signifies that mean and standard deviation were not calculable because sample concentration was below quantification limit (that is \<2.1 ng/mL).
|
—
|
—
|
—
|
—
|
|
Panel 2 and 3: Plasma Trough Concentration (C[0hour]) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763924
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
NA signifies that mean and standard deviation were not calculable because sample concentration was below quantification limit (that is \<2.1 ng/mL).
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
NA signifies that mean and standard deviation were not calculable because sample concentration was below quantification limit (that is \<2.1 ng/mL).
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 (Day 29): Pre-dose and 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dosePopulation: Pharmacokinetics (PK) analysis included Panel 2 participants who had consented to participate in intensive PK subgroup. "N" (Number of participants analyzed) = participants who were evaluable for this outcome measure. "n"(number analyzed) = number of participants analyzed at specified categories. As planned, summary analysis was performed when overall number of participants analyzed were \>=3 and thus participant wise data were reported for Panel 2 alone in this outcome measure.
Maximum observed plasma concentration (Cmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze Cmax JNJ-73763989 and its molecules.
Outcome measures
| Measure |
Panel 1
n=2 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763976 - Participant 1
|
2757 nanograms per milliliter (ng/mL)
|
—
|
—
|
—
|
—
|
—
|
|
Panel 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763976 - Participant 2
|
1062 nanograms per milliliter (ng/mL)
|
—
|
—
|
—
|
—
|
—
|
|
Panel 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763924 - Participant 1
|
595 nanograms per milliliter (ng/mL)
|
—
|
—
|
—
|
—
|
—
|
|
Panel 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763924 - Participant 2
|
205 nanograms per milliliter (ng/mL)
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 (Day 29): Pre-dose and 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dosePopulation: Pharmacokinetics (PK) analysis which included Panel 3 participants who had consented to participate in the intensive PK subgroup. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone.
Maximum observed plasma concentration (Cmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze Cmax JNJ-73763989 and its molecules.
Outcome measures
| Measure |
Panel 1
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 3: Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763976
|
924 nanograms per milliliter (ng/mL)
Standard Deviation 428
|
—
|
—
|
—
|
—
|
—
|
|
Panel 3: Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763924
|
178 nanograms per milliliter (ng/mL)
Standard Deviation 73.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 (Day 29): Pre-dose and 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dosePopulation: A pharmacokinetics (PK) analysis which included participants of Panel 2 and Panel 3 who had consented to participate in the intensive PK subgroup were analyzed. Data for this outcome measure was planned to be collected and analyzed for Panel 2 and 3 alone.
Minimum observed plasma concentration (Cmin) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze Cmin of JNJ-73763989 and its molecules
Outcome measures
| Measure |
Panel 1
n=3 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 2 and 3: Minimum Observed Plasma Concentration (Cmin) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763976
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
NA indicates that mean and standard deviation were not calculable because sample concentration was below quantification limit (that is \<2.1 ng/mL)
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
NA indicates that mean and standard deviation were not calculable because sample concentration was below quantification limit (that is \<2.1 ng/mL)
|
—
|
—
|
—
|
—
|
|
Panel 2 and 3: Minimum Observed Plasma Concentration (Cmin) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763924
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
NA indicates that mean and standard deviation were not calculable because sample concentration was below quantification limit (that is \<2.1 ng/mL)
|
NA nanograms per milliliter (ng/mL)
Standard Deviation NA
NA indicates that mean and standard deviation were not calculable because sample concentration was below quantification limit (that is \<2.1 ng/mL)
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 (Day 29): Post dose (15 minutes, 30 minutes, 1, 2, 3, 4, 6, and 24 hours)Population: Pharmacokinetics (PK) analysis included Panel 2 participants who had consented to participate in intensive PK subgroup. "N" (Number of participants analyzed) = participants who were evaluable for this outcome measure. "n"(number analyzed) = number of participants analyzed at specified categories. As planned, summary analysis was performed when overall number of participants analyzed were \>=3 and thus participant wise data were reported for Panel 2 alone in this outcome measure.
Time to reach the maximum observed plasma concentration (tmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze tmax of JNJ-73763989 and its molecules.
Outcome measures
| Measure |
Panel 1
n=2 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 2: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976,JNJ-73763924)
JNJ-73763976 - Participant 1
|
6.00 hours
|
—
|
—
|
—
|
—
|
—
|
|
Panel 2: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976,JNJ-73763924)
JNJ-73763976 - Participant 2
|
10.00 hours
|
—
|
—
|
—
|
—
|
—
|
|
Panel 2: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976,JNJ-73763924)
JNJ-73763924 - Participant 1
|
6.00 hours
|
—
|
—
|
—
|
—
|
—
|
|
Panel 2: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976,JNJ-73763924)
JNJ-73763924 - Participant 2
|
10.00 hours
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 (Day 29): Post dose (15 minutes, 30 minutes, 1, 2, 3, 4, 6, and 24 hours)Population: Pharmacokinetics (PK) analysis which included Panel 3 participants who had consented to participate in the intensive PK subgroup. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone.
Time to reach the maximum observed plasma concentration (tmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze tmax of JNJ-73763989 and its molecules.
Outcome measures
| Measure |
Panel 1
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 3:Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763976
|
6.00 hours
Interval 3.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
|
Panel 3:Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763924
|
5.04 hours
Interval 3.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 (Day 29): Pre-dose and 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dosePopulation: Pharmacokinetics (PK) analysis included Panel 2 participants who had consented to participate in intensive PK subgroup. "N" (Number of participants analyzed) = participants who were evaluable for this outcome measure. "n"(number analyzed) = number of participants analyzed at specified categories. As planned, summary analysis was performed when overall number of participants analyzed were \>=3 and thus participant wise data were reported for Panel 2 alone in this outcome measure.
Area under the plasma concentration-time curve from time zero to 24hours (AUC0 to 24h) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze AUC0 to 24h of JNJ-73763989 and its molecules.
Outcome measures
| Measure |
Panel 1
n=2 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 2: Area Under the Plasma Concentration-time Curve From Time Zero to 24hours (AUC0 to 24h) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763976 - Participant 1
|
27744 nanograms*hour per milliliters (ng*h/mL)
|
—
|
—
|
—
|
—
|
—
|
|
Panel 2: Area Under the Plasma Concentration-time Curve From Time Zero to 24hours (AUC0 to 24h) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763976 - Participant 2
|
13820 nanograms*hour per milliliters (ng*h/mL)
|
—
|
—
|
—
|
—
|
—
|
|
Panel 2: Area Under the Plasma Concentration-time Curve From Time Zero to 24hours (AUC0 to 24h) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763924 - Participant 1
|
5388 nanograms*hour per milliliters (ng*h/mL)
|
—
|
—
|
—
|
—
|
—
|
|
Panel 2: Area Under the Plasma Concentration-time Curve From Time Zero to 24hours (AUC0 to 24h) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763924 - Participant 2
|
2649 nanograms*hour per milliliters (ng*h/mL)
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 (Day 29): Pre-dose and 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 24 hours post dosePopulation: A pharmacokinetics (PK) analysis which included participants of Panel 3 who had consented to participate in the intensive PK subgroup. Data for this outcome measure was planned to be collected and analyzed for Panel 3 alone.
Area under the plasma concentration-time curve from time zero to 24hours (AUC0 to 24h) of JNJ-73763989 (JNJ-73763976, JNJ-73763924) were reported. Non-compartmental analysis were conducted to analyze AUC0 to 24h of JNJ-73763989 and its molecules.
Outcome measures
| Measure |
Panel 1
n=4 Participants
Prior to PA 5, participants received either JNJ-3989 200 milligrams (mg) subcutaneous(SC) injection every 4 weeks(Q4W) from Day 1 (Week 1) to Week 44+JNJ-6379 250 mg once daily(QD)+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment:PegIFN-alpha-2a 180 micrograms(mcg) SC injection once weekly(QW) post Week 40 liver biopsy for either 12/24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase; stopped JNJ-3989/JNJ-6379 and NA ( if NA completion criteria \[NAcc:alanine aminotransferase {ALT} less than {\<}3\*upper limit of normal{ULN}, HB virus deoxyribonucleic acid {HBV DNA} \<lower limit of quantification {LLOQ}:20 International Units per milliliter {IU/mL}\], HBeAg negative \& HB surface antigen {HBsAg} \<10 IU/mL\] was met as per Week 44 laboratory tests). If NAcc were not met, NA was continued till FU end (study Week 96). Participants on PegIN-alpha2a and who had not met NAcc at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NAcc was met; then entered FU. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU, NA was re-started.
|
Panel 2
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a and who had not met NA completion criteria at Week 48 were assessed at end of PegIN-alpha2a treatment and stopped NA, if completion criteria met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL and ALT \>5\*ULN) were met in FU phase, NA retreatment was started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 1
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
After completion of OL phase (up to Week 48), Panel 3 participants enrolled per PA 5, entered FU phase and stopped JNJ-3989 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
|---|---|---|---|---|---|---|
|
Panel 3: Area Under the Plasma Concentration-time Curve From Time Zero to 24hours (AUC0 to 24h) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763976
|
13,256 nanograms*hour per milliliters (ng*h/mL)
Standard Deviation 6,314
|
—
|
—
|
—
|
—
|
—
|
|
Panel 3: Area Under the Plasma Concentration-time Curve From Time Zero to 24hours (AUC0 to 24h) of JNJ-73763989 (JNJ-73763976, JNJ-73763924)
JNJ-73763924
|
2,394 nanograms*hour per milliliters (ng*h/mL)
Standard Deviation 1,047
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
OL Phase: Panel 1
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
OL Phase: Panel 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
OL Phase: Panel 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
FU Phase: Panel 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
FU Phase: Panel 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
FU Phase: Panel 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OL Phase: Panel 1
n=10 participants at risk
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment: PegIFN-alpha-2a 180 mcg SC injection QW post Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at Week 48, NA was continued till FU phase end (study Week 96).
|
OL Phase: Panel 2
n=10 participants at risk
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at Week 48, NA was continued till FU phase end (study Week 96).
|
OL Phase: Panel 3
n=4 participants at risk
After PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at Week 48, NA was continued till FU phase end (study Week 96).
|
FU Phase: Panel 1
n=10 participants at risk
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
n=10 participants at risk
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
n=4 participants at risk
After completion of open-label study intervention phase (up to 48 weeks) all participants (HBeAg positive or negative who were either not currently treated or virologically suppressed by ETV or TD treatment) enrolled per PA 5, entered follow-up phase and stopped all study drugs (JNJ-3989 200 mg SC injection) including NA treatment \[ETV 0.5 mg, TD 245 mg/TAF 25 mg\], but NA treatment continued till end of follow-up (study Week 96), if NA treatment completion criteria (\[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\]) was not met at Week 48. Participants who were on treatment with optional PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy but had not met NA treatment completion criteria at Week 48, were assessed at the end of treatment with PegIFN-α2a (study Week 60 or 72) and stopped NA, if the NA treatment completion criteria were met. Participants who met NA treatment completion criteria (at Week 48) were monitored Q4W in follow-up phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met, NA retreatment was started.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
Other adverse events
| Measure |
OL Phase: Panel 1
n=10 participants at risk
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48 or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44+NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants stopped JNJ-6379 and continued JNJ-3989+NA. With separate consent, participants received optional treatment: PegIFN-alpha-2a 180 mcg SC injection QW post Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at Week 48, NA was continued till FU phase end (study Week 96).
|
OL Phase: Panel 2
n=10 participants at risk
Prior to PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at Week 48, NA was continued till FU phase end (study Week 96).
|
OL Phase: Panel 3
n=4 participants at risk
After PA 5, participants received either JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + JNJ-6379 250 mg QD and NA treatment (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48, or JNJ-3989 200 mg SC injection Q4W from Day 1 (Week 1) to Week 44 + NA (ETV 0.5 mg/TD 245 mg/TAF 25 mg) QD from Day 1 (Week 1) to Week 48. After PA 5, participants discontinued JNJ-6379 and continued JNJ-3989 + NA. With separate consent, participants received optional treatment with PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy for either 12 or 24 weeks (anytime between study Week 40 to 72) at investigator's discretion. At end of treatment Week 48, all participants entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA treatment completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at Week 48, NA was continued till FU phase end (study Week 96).
|
FU Phase: Panel 1
n=10 participants at risk
After completion of OL phase (up to Week 48), Panel 1 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 2
n=10 participants at risk
After completion of OL phase (up to Week 48), Panel 2 participants enrolled prior to PA 5, entered FU phase and stopped JNJ-3989/JNJ-6379 and NA (if NA completion criteria \[ALT \<3\*ULN, HBV DNA \<LLOQ:20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\] was met as per Week 44 laboratory tests). If NA completion criteria were not met at OL Week 48, NA was continued till FU phase end (study Week 96). Participants on PegIN-alpha2a 180 mcg SC injection QW after Week 40 liver biopsy (for either 12 or 24 weeks) and who had not met NA completion criteria at Week 48 were assessed at PegIN-alpha2a treatment end and stopped NA, if NA completion criteria was met and then entered FU phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met in FU phase, NA was re-started.
|
FU Phase: Panel 3
n=4 participants at risk
After completion of open-label study intervention phase (up to 48 weeks) all participants (HBeAg positive or negative who were either not currently treated or virologically suppressed by ETV or TD treatment) enrolled per PA 5, entered follow-up phase and stopped all study drugs (JNJ-3989 200 mg SC injection) including NA treatment \[ETV 0.5 mg, TD 245 mg/TAF 25 mg\], but NA treatment continued till end of follow-up (study Week 96), if NA treatment completion criteria (\[ALT \<3\*ULN, HBV DNA \<LLOQ; 20 IU/mL, HBeAg negative and HBsAg \<10 IU/mL\]) was not met at Week 48. Participants who were on treatment with optional PegIFN-alpha-2a 180 mcg SC injection QW after Week 40 liver biopsy but had not met NA treatment completion criteria at Week 48, were assessed at the end of treatment with PegIFN-α2a (study Week 60 or 72) and stopped NA, if the NA treatment completion criteria were met. Participants who met NA treatment completion criteria (at Week 48) were monitored Q4W in follow-up phase. If NA-retreatment criteria (HBV DNA \>20,000 IU/mL, HBV DNA \>2,000 IU/mL but \<20,000 IU/mL \& ALT \>5\*ULN) was met, NA retreatment was started.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
25.0%
1/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
25.0%
1/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Gastrointestinal Sounds Abnormal
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Lip Blister
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
General disorders
Asthenia
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
25.0%
1/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
50.0%
2/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
General disorders
Chills
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
General disorders
Fatigue
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
25.0%
1/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
General disorders
Injection Site Bruising
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
General disorders
Injection Site Erythema
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
General disorders
Injection Site Pain
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
General disorders
Injection Site Reaction
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
25.0%
1/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Covid-19
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
25.0%
1/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Root Canal Infection
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Tinea Versicolour
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Investigations
Amylase Increased
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Investigations
Body Temperature Increased
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Investigations
Low Density Lipoprotein Increased
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Investigations
Weight Decreased
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
30.0%
3/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
25.0%
1/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
25.0%
1/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Psychiatric disorders
Mood Swings
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Renal and urinary disorders
Renal Tubular Disorder
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
20.0%
2/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
10.0%
1/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/10 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
0.00%
0/4 • Open-label phase: From Day 1 (Week 1) up to Week 48; Follow-up Phase: Follow-up Week 1 up to follow-up Week 48
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
|
Additional Information
Executive Medical Director
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place