Trial Outcomes & Findings for A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection (NCT NCT03576066)
NCT ID: NCT03576066
Last Updated: 2021-02-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2021-02-17
Participant Flow
Participant milestones
| Measure |
ABI-H0731 + SOC NUC
Virologically suppressed participants will receive ABI-H0731 along with standard of care (SOC) nucleos(t)ide reverse transcriptase inhibitor (NUC) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
Placebo + SOC NUC
Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
28
|
|
Overall Study
COMPLETED
|
45
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
ABI-H0731 + SOC NUC
Virologically suppressed participants will receive ABI-H0731 along with standard of care (SOC) nucleos(t)ide reverse transcriptase inhibitor (NUC) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
Placebo + SOC NUC
Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|
|
Overall Study
Noncompliance with study drug
|
0
|
1
|
Baseline Characteristics
A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection
Baseline characteristics by cohort
| Measure |
ABI-H0731 + SOC NUC
n=45 Participants
Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
Placebo + SOC NUC
n=28 Participants
Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 10.26 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 11.32 • n=7 Participants
|
45.3 years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
37 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
24 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Hepatitis B "e" Antigen (HBeAg) status
HBeAg Positive
|
29 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Hepatitis B "e" Antigen (HBeAg) status
HBeAg Negative
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Intention-to-treat (ITT) population: all randomized participants. Results were analyzed and reported based on Baseline HBeAg status: positive or negative, for available data at Baseline, Week 24, or both.
Outcome measures
| Measure |
HBeAg-positive Participants: ABI-H0731 + SOC NUC
n=29 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-positive Participants: Placebo + SOC NUC
n=18 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
HBeAg-negative Participants: ABI-H0731 + SOC NUC
n=16 Participants
Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-negative Participants: Placebo + SOC NUC
n=10 Participants
Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|
|
Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Baseline
|
3.48 Log10 International Units (IU)/mL
Standard Deviation 0.401
|
3.57 Log10 International Units (IU)/mL
Standard Deviation 0.516
|
2.99 Log10 International Units (IU)/mL
Standard Deviation 0.555
|
3.35 Log10 International Units (IU)/mL
Standard Deviation 0.648
|
|
Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Change from baseline
|
0.03 Log10 International Units (IU)/mL
Standard Deviation 0.138
|
0.03 Log10 International Units (IU)/mL
Standard Deviation 0.054
|
0.09 Log10 International Units (IU)/mL
Standard Deviation 0.133
|
-0.00 Log10 International Units (IU)/mL
Standard Deviation 0.021
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: ITT population. Results were analyzed and reported only for participants who were HBeAg positive at Baseline and had available data at Baseline, Week 24, or both.
Outcome measures
| Measure |
HBeAg-positive Participants: ABI-H0731 + SOC NUC
n=29 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-positive Participants: Placebo + SOC NUC
n=18 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
HBeAg-negative Participants: ABI-H0731 + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-negative Participants: Placebo + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|
|
Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Baseline
|
0.55 Log10 International Units (IU)/mL
Standard Deviation 0.980
|
0.43 Log10 International Units (IU)/mL
Standard Deviation 0.964
|
—
|
—
|
|
Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Change from baseline
|
-0.05 Log10 International Units (IU)/mL
Standard Deviation 0.191
|
-0.10 Log10 International Units (IU)/mL
Standard Deviation 0.193
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Follow-up (maximum up to Week 36)Population: Safety population: all randomized participants who received any amount of study drug
Outcome measures
| Measure |
HBeAg-positive Participants: ABI-H0731 + SOC NUC
n=45 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-positive Participants: Placebo + SOC NUC
n=28 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
HBeAg-negative Participants: ABI-H0731 + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-negative Participants: Placebo + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|
|
Number of Participants With One or More Adverse Events
|
24 Participants
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Follow-up (maximum up to Week 36)Population: ITT population
Outcome measures
| Measure |
HBeAg-positive Participants: ABI-H0731 + SOC NUC
n=45 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-positive Participants: Placebo + SOC NUC
n=28 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
HBeAg-negative Participants: ABI-H0731 + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-negative Participants: Placebo + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|
|
Number of Participants With Premature Study Discontinuation
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 36Population: Safety population
Outcome measures
| Measure |
HBeAg-positive Participants: ABI-H0731 + SOC NUC
n=45 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-positive Participants: Placebo + SOC NUC
n=28 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
HBeAg-negative Participants: ABI-H0731 + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-negative Participants: Placebo + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|
|
Number of Participants With One or More Abnormal Safety Laboratory Result
|
27 Participants
|
20 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Safety population
Outcome measures
| Measure |
HBeAg-positive Participants: ABI-H0731 + SOC NUC
n=45 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-positive Participants: Placebo + SOC NUC
n=28 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
HBeAg-negative Participants: ABI-H0731 + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-negative Participants: Placebo + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|
|
Number of Participants With a Clinically-significant Electrocardiogram Abnormality
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and up to Week 24Population: Safety population
Vital signs assessed were body temperature, respiratory rate, and pulse rate
Outcome measures
| Measure |
HBeAg-positive Participants: ABI-H0731 + SOC NUC
n=45 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-positive Participants: Placebo + SOC NUC
n=28 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
HBeAg-negative Participants: ABI-H0731 + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-negative Participants: Placebo + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|
|
Number of Participants With a Clinically-significant Change in Vital Signs
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants in the ITT population with abnormal ALT at Baseline
Abnormal ALT was defined as ≥1.25 x upper limit of normal (34 Units/L for female and 43 Units/L for male participants).
Outcome measures
| Measure |
HBeAg-positive Participants: ABI-H0731 + SOC NUC
n=2 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-positive Participants: Placebo + SOC NUC
n=1 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
HBeAg-negative Participants: ABI-H0731 + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-negative Participants: Placebo + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24Population: Safety population. Results were analyzed and reported only for participants who received ABI-H0731 + SOC NUC and had ABI-H0731 pharmacokinetic data assessments available.
Outcome measures
| Measure |
HBeAg-positive Participants: ABI-H0731 + SOC NUC
n=45 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-positive Participants: Placebo + SOC NUC
Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
HBeAg-negative Participants: ABI-H0731 + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-negative Participants: Placebo + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|
|
Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
Baseline (Day 1)
|
0.436 ng/mL
Standard Deviation 2.92
|
—
|
—
|
—
|
|
Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
Week 2
|
1390 ng/mL
Standard Deviation 647
|
—
|
—
|
—
|
|
Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
Week 4
|
1390 ng/mL
Standard Deviation 632
|
—
|
—
|
—
|
|
Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
Week 12
|
1330 ng/mL
Standard Deviation 560
|
—
|
—
|
—
|
|
Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
Week 24
|
1330 ng/mL
Standard Deviation 526
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24Population: Safety population. Results were analyzed and reported only for participants who received ETV as their SOC NUC and had ETV pharmacokinetic data assessments available.
Outcome measures
| Measure |
HBeAg-positive Participants: ABI-H0731 + SOC NUC
n=7 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-positive Participants: Placebo + SOC NUC
n=3 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
HBeAg-negative Participants: ABI-H0731 + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-negative Participants: Placebo + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|
|
Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Baseline (Day 1)
|
1.10 ng/mL
Standard Deviation 1.88
|
1.78 ng/mL
Standard Deviation 1.77
|
—
|
—
|
|
Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Week 2
|
0.554 ng/mL
Standard Deviation 0.261
|
0.346 ng/mL
Standard Deviation 0.124
|
—
|
—
|
|
Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Week 4
|
0.872 ng/mL
Standard Deviation 1.04
|
0.621 ng/mL
Standard Deviation 0.460
|
—
|
—
|
|
Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Week 12
|
0.583 ng/mL
Standard Deviation 0.363
|
0.704 ng/mL
Standard Deviation 0.403
|
—
|
—
|
|
Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Week 24
|
1.04 ng/mL
Standard Deviation 1.57
|
0.739 ng/mL
Standard Deviation 0.0902
|
—
|
—
|
SECONDARY outcome
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24Population: Safety population. Results were analyzed and reported only for participants who received TAF as their SOC NUC and had TAF pharmacokinetic data assessments available.
Outcome measures
| Measure |
HBeAg-positive Participants: ABI-H0731 + SOC NUC
n=14 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-positive Participants: Placebo + SOC NUC
n=8 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
HBeAg-negative Participants: ABI-H0731 + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-negative Participants: Placebo + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|
|
Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Baseline (Day 1)
|
9.67 ng/mL
Standard Deviation 3.43
|
12.2 ng/mL
Standard Deviation 6.52
|
—
|
—
|
|
Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Week 2
|
13.1 ng/mL
Standard Deviation 4.73
|
14.1 ng/mL
Standard Deviation 6.95
|
—
|
—
|
|
Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Week 4
|
21.3 ng/mL
Standard Deviation 25.3
|
11.8 ng/mL
Standard Deviation 4.52
|
—
|
—
|
|
Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Week 12
|
18.4 ng/mL
Standard Deviation 14.3
|
11.7 ng/mL
Standard Deviation 3.66
|
—
|
—
|
|
Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Week 24
|
18.9 ng/mL
Standard Deviation 18.2
|
13.3 ng/mL
Standard Deviation 3.26
|
—
|
—
|
SECONDARY outcome
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24Population: Safety population. Results were analyzed and reported only for participants who received TDF as their SOC NUC and had TDF pharmacokinetic data assessments available.
Outcome measures
| Measure |
HBeAg-positive Participants: ABI-H0731 + SOC NUC
n=23 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-positive Participants: Placebo + SOC NUC
n=15 Participants
Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
HBeAg-negative Participants: ABI-H0731 + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
HBeAg-negative Participants: Placebo + SOC NUC
Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|---|---|
|
Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Baseline (Day 1)
|
77.5 ng/mL
Standard Deviation 52.1
|
89.1 ng/mL
Standard Deviation 71.4
|
—
|
—
|
|
Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Week 2
|
85.5 ng/mL
Standard Deviation 49.3
|
76.2 ng/mL
Standard Deviation 21.5
|
—
|
—
|
|
Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Week 4
|
86.8 ng/mL
Standard Deviation 58.2
|
84.1 ng/mL
Standard Deviation 60.3
|
—
|
—
|
|
Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Week 12
|
79.3 ng/mL
Standard Deviation 68.1
|
86.7 ng/mL
Standard Deviation 47.4
|
—
|
—
|
|
Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Week 24
|
79.3 ng/mL
Standard Deviation 45.3
|
78.3 ng/mL
Standard Deviation 44.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 12, and 24Population: Trough to peak ratios were not calculated due to an insufficient number of optional peak exposure samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 12, and 24Population: Trough to peak ratios were not calculated due to an insufficient number of optional peak exposure samples.
Outcome measures
Outcome data not reported
Adverse Events
ABI-H0731 + SOC NUC
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo + SOC NUC
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ABI-H0731 + SOC NUC
n=45 participants at risk
Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
ABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.
SOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.
|
Placebo + SOC NUC
n=28 participants at risk
Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
SOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
5/45 • Number of events 5 • Up to Week 36
Safety population
|
3.6%
1/28 • Number of events 1 • Up to Week 36
Safety population
|
|
Gastrointestinal disorders
Nausea
|
8.9%
4/45 • Number of events 4 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
3/45 • Number of events 4 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
7.1%
2/28 • Number of events 2 • Up to Week 36
Safety population
|
|
Infections and infestations
Influenza
|
4.4%
2/45 • Number of events 2 • Up to Week 36
Safety population
|
3.6%
1/28 • Number of events 1 • Up to Week 36
Safety population
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
2/45 • Number of events 2 • Up to Week 36
Safety population
|
3.6%
1/28 • Number of events 1 • Up to Week 36
Safety population
|
|
Infections and infestations
Urinary tract infection
|
4.4%
2/45 • Number of events 2 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Infections and infestations
Viral infection
|
0.00%
0/45 • Up to Week 36
Safety population
|
3.6%
1/28 • Number of events 1 • Up to Week 36
Safety population
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
3.6%
1/28 • Number of events 1 • Up to Week 36
Safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
2/45 • Number of events 2 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
4.4%
2/45 • Number of events 2 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Infections and infestations
Bacterial vaginosis
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Infections and infestations
Conjunctivitis
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Infections and infestations
Gastroenteritis
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Infections and infestations
Onychomycosis
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Infections and infestations
Oral herpes
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Gastrointestinal disorders
Abdominal distension
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Gastrointestinal disorders
Flatulence
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Gastrointestinal disorders
Tongue ulceration
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.4%
2/45 • Number of events 2 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
General disorders
Pyrexia
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
3.6%
1/28 • Number of events 2 • Up to Week 36
Safety population
|
|
General disorders
Fatigue
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
3.6%
1/28 • Number of events 1 • Up to Week 36
Safety population
|
|
General disorders
Chest discomfort
|
0.00%
0/45 • Up to Week 36
Safety population
|
3.6%
1/28 • Number of events 1 • Up to Week 36
Safety population
|
|
General disorders
Inflammation
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
3.6%
1/28 • Number of events 1 • Up to Week 36
Safety population
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/45 • Up to Week 36
Safety population
|
3.6%
1/28 • Number of events 1 • Up to Week 36
Safety population
|
|
Nervous system disorders
Headache
|
4.4%
2/45 • Number of events 2 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Nervous system disorders
Dizziness
|
0.00%
0/45 • Up to Week 36
Safety population
|
3.6%
1/28 • Number of events 1 • Up to Week 36
Safety population
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.4%
2/45 • Number of events 2 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/45 • Up to Week 36
Safety population
|
3.6%
1/28 • Number of events 1 • Up to Week 36
Safety population
|
|
Hepatobiliary disorders
Hepatic pain
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Hepatobiliary disorders
Liver tenderness
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Cardiac disorders
Palpitations
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Immune system disorders
Seasonal allergy
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Psychiatric disorders
Libido decreased
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
|
Vascular disorders
Hot flush
|
2.2%
1/45 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/28 • Up to Week 36
Safety population
|
Additional Information
Linda Bahr, Sr. Director, Clinical Operations
Assembly Biosciences
Phone: 415-521-3808
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Assembly Biosciences agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Assembly Biosciences supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER