Trial Outcomes & Findings for A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients (NCT NCT03780543)
NCT ID: NCT03780543
Last Updated: 2023-04-19
Results Overview
To evaluate the potential for combination therapy with ABI-H0731+ NrtI to increase SVR rates in subjects who have chronic hepatitis B (CHB). To evaluate the proportion of subjects who meet the definition of SVR at 24 weeks off treatment, the SVR rate and corresponding 95% confidence interval will be presented for the overall population while on combination therapy. SVR is defined as sustained viral response with HBV DNA , LOQ (20 IU/mL) through off-treatment Week 24.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
Completing from week 52 until week 76
Results posted on
2023-04-19
Participant Flow
Participant milestones
| Measure |
Virologically Suppressed HBeAg-negative Participants From Parent Study ABI-H0731-201
Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care nucleos(t)ide (SOC NrtI)-suppressed and HBeAg-negative will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years.
ABI-H0731: Participants will receive 300 mg quaque die (QD) of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
|
Virologically Suppressed HBeAg-positive Participants From Parent Study ABI-H0731-201
Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. Subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
|
HBeAg Positive Participants From Parent Study ABI-H0731-202
Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.
Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148. Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years, while those subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
ABI-H0731: Participants will receive 300 mg quaque die (QD) of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) or Tenofovir alafenamide (TAF) tablet QD orally as per approved package insert.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
43
|
23
|
|
Overall Study
COMPLETED
|
13
|
28
|
6
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
17
|
Reasons for withdrawal
| Measure |
Virologically Suppressed HBeAg-negative Participants From Parent Study ABI-H0731-201
Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care nucleos(t)ide (SOC NrtI)-suppressed and HBeAg-negative will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years.
ABI-H0731: Participants will receive 300 mg quaque die (QD) of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
|
Virologically Suppressed HBeAg-positive Participants From Parent Study ABI-H0731-201
Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. Subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
|
HBeAg Positive Participants From Parent Study ABI-H0731-202
Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.
Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148. Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years, while those subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
ABI-H0731: Participants will receive 300 mg quaque die (QD) of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) or Tenofovir alafenamide (TAF) tablet QD orally as per approved package insert.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
|
Overall Study
Study terminated by Sponsor
|
8
|
7
|
13
|
|
Overall Study
Withdrawal by Subject
|
1
|
8
|
1
|
|
Overall Study
Noncompliance with study drug
|
1
|
0
|
0
|
Baseline Characteristics
A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
Baseline characteristics by cohort
| Measure |
Virologically Suppressed HBeAg-negative Participants From Parent Study ABI-H0731-201
n=26 Participants
Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care nucleos(t)ide (SOC NrtI)-suppressed and HBeAg-negative will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years.
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
|
Virologically Suppressed HBeAg-positive Participants From Parent Study ABI-H0731-201
n=43 Participants
Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. Subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
|
HBeAg Positive Participants From Parent Study ABI-H0731-202
n=23 Participants
Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.
Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148. Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years, while those subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
45 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
36 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
44 years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
52 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
|
20 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
New Zealand
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
Hong Kong
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Body Mass Index
|
24.38 kg/m 2
STANDARD_DEVIATION 2.922 • n=5 Participants
|
23.97 kg/m 2
STANDARD_DEVIATION 3.583 • n=7 Participants
|
23.47 kg/m 2
STANDARD_DEVIATION 3.984 • n=5 Participants
|
23.96 kg/m 2
STANDARD_DEVIATION 3.496 • n=4 Participants
|
PRIMARY outcome
Timeframe: Completing from week 52 until week 76Population: Participants who met the protocol-specific treatment action criteria to discontinue treatment with ABI-H0731 and NrtI after completing 52 weeks of treatment were analyzed for sustained viral repones at 24 weeks off treatment. (i.e., Completing from week 52 (treatment discharge) until week 76 (24 weeks off treatment)
To evaluate the potential for combination therapy with ABI-H0731+ NrtI to increase SVR rates in subjects who have chronic hepatitis B (CHB). To evaluate the proportion of subjects who meet the definition of SVR at 24 weeks off treatment, the SVR rate and corresponding 95% confidence interval will be presented for the overall population while on combination therapy. SVR is defined as sustained viral response with HBV DNA , LOQ (20 IU/mL) through off-treatment Week 24.
Outcome measures
| Measure |
Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201
n=23 Participants
All participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.
|
Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201
n=18 Participants
Participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.
|
Treatment-naïve Subjects With HBeAg Positive cHBV
Treatment-naïve subjects with Hepatitis B "e" antigen (HBeAG) positive status with chronic hepatitis B virus (cHBV) from Study ABI-H0731-202 (Parent Study 202)
|
|---|---|---|---|
|
Sustained Viral Response (SVR) at 24 Weeks Off Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 148Population: Safety population included all who received at least 1 dose of study drug.
Incidence of treatment emergent adverse events (AEs)
Outcome measures
| Measure |
Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201
n=26 Participants
All participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.
|
Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201
n=43 Participants
Participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.
|
Treatment-naïve Subjects With HBeAg Positive cHBV
n=23 Participants
Treatment-naïve subjects with Hepatitis B "e" antigen (HBeAG) positive status with chronic hepatitis B virus (cHBV) from Study ABI-H0731-202 (Parent Study 202)
|
|---|---|---|---|
|
Number of Subjects With Adverse Events
Number of subjects with AEs
|
16 Participants
|
26 Participants
|
12 Participants
|
|
Number of Subjects With Adverse Events
Number of subjects with discontinuation due to an AE
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Adverse Events
Number of subjects with significant abnormal ECGs
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: EOT: up to Week 52 or 148; EOS: up to 3 years off treatmentPopulation: Number/proportion of subjects with normal alanine aminotransferase (ALT) at end of treatment (EOT) and end of study (EOS)
To measure the number and proportion of subjects with abnormal ALT at baseline who have normal ALT at end of treatment (EOT) and end of study (EOS) To measure the number and proportion of subjects regardless of levels of ALT at baseline at EOT and EOS
Outcome measures
| Measure |
Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201
n=2 Participants
All participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.
|
Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201
n=2 Participants
Participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.
|
Treatment-naïve Subjects With HBeAg Positive cHBV
n=7 Participants
Treatment-naïve subjects with Hepatitis B "e" antigen (HBeAG) positive status with chronic hepatitis B virus (cHBV) from Study ABI-H0731-202 (Parent Study 202)
|
|---|---|---|---|
|
Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS)
Numbers with normal ALT levels at EOT
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS)
Number with normal ALT levels at EOS
|
1 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: upto Week 148Population: The proportion of subjects with hepatitis B virus (HBV) DNA target not detected (TND). Treatment-naïve Subjects With HBeAg Positive cHBV was not collected. No entry has been made in the column.
Incidence of subjects with suppression/loss of viral Hepatitis B "e" antigen (HBeAg) antigen/DNA on combination treatment whose viral antigens rebound off therapy
Outcome measures
| Measure |
Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201
n=25 Participants
All participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.
|
Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201
n=4 Participants
Participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.
|
Treatment-naïve Subjects With HBeAg Positive cHBV
Treatment-naïve subjects with Hepatitis B "e" antigen (HBeAG) positive status with chronic hepatitis B virus (cHBV) from Study ABI-H0731-202 (Parent Study 202)
|
|---|---|---|---|
|
Number of Subjects With Suppression/Loss of Viral HBeAg Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy
|
4 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 148Population: Subjects from the parent study 201 with positive or negative Hepatitis B "e" antigen (HBeAg) Treatment-naïve Subjects With HBeAg Positive cHBV was not collected. No entry has been made in the column.
Incidence of subjects with suppression/loss of viral core-related antigen (HBcrAg) or DNA on combination treatment whose viral antigens rebound off treatment
Outcome measures
| Measure |
Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201
n=11 Participants
All participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.
|
Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201
Participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.
|
Treatment-naïve Subjects With HBeAg Positive cHBV
Treatment-naïve subjects with Hepatitis B "e" antigen (HBeAG) positive status with chronic hepatitis B virus (cHBV) from Study ABI-H0731-202 (Parent Study 202)
|
|---|---|---|---|
|
Number of Subjects With Suppression/Loss of Viral Core-related Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy
|
7 Participants
|
0 Participants
|
—
|
Adverse Events
Virologically Suppressed HBeAg-negative Participants From Parent Study ABI-H0731-201
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Virologically Suppressed HBeAg-positive Participants From Parent Study ABI-H0731-201
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
HBeAg Positive Participants From Parent Study ABI-H0731-202
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Virologically Suppressed HBeAg-negative Participants From Parent Study ABI-H0731-201
n=26 participants at risk
Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care nucleos(t)ide (SOC NrtI)-suppressed and HBeAg-negative will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years.
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
|
Virologically Suppressed HBeAg-positive Participants From Parent Study ABI-H0731-201
n=43 participants at risk
Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. Subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
|
HBeAg Positive Participants From Parent Study ABI-H0731-202
n=23 participants at risk
Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.
Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148. Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years, while those subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
|
|---|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/26 • Up to Week 148
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.
|
0.00%
0/43 • Up to Week 148
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.
|
4.3%
1/23 • Up to Week 148
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.
|
Other adverse events
| Measure |
Virologically Suppressed HBeAg-negative Participants From Parent Study ABI-H0731-201
n=26 participants at risk
Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care nucleos(t)ide (SOC NrtI)-suppressed and HBeAg-negative will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years.
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
|
Virologically Suppressed HBeAg-positive Participants From Parent Study ABI-H0731-201
n=43 participants at risk
Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. Subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
|
HBeAg Positive Participants From Parent Study ABI-H0731-202
n=23 participants at risk
Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.
Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148. Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years, while those subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
|
|---|---|---|---|
|
Infections and infestations
upper respiratory tract infection
|
11.5%
3/26 • Up to Week 148
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.
|
14.0%
6/43 • Up to Week 148
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.
|
4.3%
1/23 • Up to Week 148
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
1/26 • Up to Week 148
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.
|
7.0%
3/43 • Up to Week 148
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.
|
8.7%
2/23 • Up to Week 148
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.
|
|
General disorders
fatique
|
3.8%
1/26 • Up to Week 148
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.
|
7.0%
3/43 • Up to Week 148
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.
|
4.3%
1/23 • Up to Week 148
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60