Trial Outcomes & Findings for A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV) (NCT NCT03577171)
NCT ID: NCT03577171
Last Updated: 2021-01-28
Results Overview
Hepatitis B virus (HBV) DNA was measured using COBAS TaqMan Version 2.0. The lower limit of quantitation (LLOQ) was 20 IU/mL and the limit of detection (LOD) was 10 IU/mL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline, Week 12, and Week 24
Results posted on
2021-01-28
Participant Flow
Participant milestones
| Measure |
ABI-H0731 + SOC ETV
Participants with chronic hepatitis B infection (cHBV) who are currently not being treated will receive ABI-H0731 along with standard of care (SOC) entecavir (ETV) 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
Baseline characteristics by cohort
| Measure |
ABI-H0731 + SOC ETV
n=13 Participants
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
n=12 Participants
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 14.13 • n=5 Participants
|
34.1 years
STANDARD_DEVIATION 11.39 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 12.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 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
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: Intent-to-treat (ITT) population: all randomized participants
Hepatitis B virus (HBV) DNA was measured using COBAS TaqMan Version 2.0. The lower limit of quantitation (LLOQ) was 20 IU/mL and the limit of detection (LOD) was 10 IU/mL.
Outcome measures
| Measure |
ABI-H0731 + SOC ETV
n=13 Participants
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
n=12 Participants
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
|---|---|---|
|
Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV
Baseline
|
7.91 Log10 International Units (IU)/mL
Standard Deviation 0.890
|
8.03 Log10 International Units (IU)/mL
Standard Deviation 0.999
|
|
Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV
Change from Baseline at Week 12
|
-4.45 Log10 International Units (IU)/mL
Standard Deviation 1.027
|
-3.30 Log10 International Units (IU)/mL
Standard Deviation 1.182
|
|
Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV
Change from Baseline at Week 24
|
-5.33 Log10 International Units (IU)/mL
Standard Deviation 1.594
|
-4.20 Log10 International Units (IU)/mL
Standard Deviation 0.976
|
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 |
ABI-H0731 + SOC ETV
n=13 Participants
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
n=12 Participants
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
|---|---|---|
|
Number of Participants One or More Adverse Events
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to Follow-up (maximum up to Week 36)Population: ITT population
Outcome measures
| Measure |
ABI-H0731 + SOC ETV
n=13 Participants
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
n=12 Participants
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
|---|---|---|
|
Number of Participants With Premature Study Discontinuation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 36Population: Safety population: all randomized participants who received any amount of study drug
Outcome measures
| Measure |
ABI-H0731 + SOC ETV
n=13 Participants
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
n=12 Participants
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
|---|---|---|
|
Number of Participants With One or More Abnormal Safety Laboratory Result
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Safety population: all randomized participants who received any amount of study drug
Outcome measures
| Measure |
ABI-H0731 + SOC ETV
n=13 Participants
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
n=12 Participants
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
|---|---|---|
|
Number of Participants With a Clinically-significant Electrocardiogram Abnormality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 24Population: Safety population: all randomized participants who received any amount of study drug
Vital signs assessed were body temperature, respiratory rate, and pulse rate
Outcome measures
| Measure |
ABI-H0731 + SOC ETV
n=13 Participants
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
n=12 Participants
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
|---|---|---|
|
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
Outcome measures
| Measure |
ABI-H0731 + SOC ETV
n=4 Participants
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
n=4 Participants
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
|---|---|---|
|
Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24Population: ITT population and had viral DNA data available
HBV DNA was measured using COBAS TaqMan Version 2.0. The LLOQ was 20 IU/mL and the LOD was 10 IU/mL. The number of participants with HBV DNA below the limit of quantitation (\<20 IU/mL) and target detected (≥10 IU/mL) was assessed.
Outcome measures
| Measure |
ABI-H0731 + SOC ETV
n=13 Participants
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
n=12 Participants
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
|---|---|---|
|
Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Week 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Week 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Week 8
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Week 12
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Week 16
|
2 Participants
|
0 Participants
|
|
Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Week 20
|
1 Participants
|
1 Participants
|
|
Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Week 24
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24Population: Median time to viral suppression could not be calculated because fewer than 50% of participants achieved viral suppression within 24 weeks.
Median time to viral suppression will be calculated and evaluated between participants on ABI-H0731 + ETV as compared to placebo + ETV.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 36Population: ITT population
Emergence of a resistant HBV variant was defined as an increase of ≥1 log10 IU/mL from the nadir in HBV DNA.
Outcome measures
| Measure |
ABI-H0731 + SOC ETV
n=13 Participants
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
n=12 Participants
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
|---|---|---|
|
Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Emergence of resistant HBV variants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
No emergence of resistant HBV variants
|
12 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24Population: Results were analyzed and reported only for participants in the safety population who received ABI-H0731 + SOC ETV and had ABI-H0731 pharmacokinetic data assessments available.
Outcome measures
| Measure |
ABI-H0731 + SOC ETV
n=13 Participants
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
|---|---|---|
|
Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy
Baseline (Day 1)
|
NA ng/mL
Standard Deviation NA
Plasma levels for all participants were below the limit of quantitation
|
—
|
|
Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy
Week 2
|
1480 ng/mL
Standard Deviation 458
|
—
|
|
Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy
Week 4
|
1290 ng/mL
Standard Deviation 434
|
—
|
|
Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy
Week 12
|
1270 ng/mL
Standard Deviation 413
|
—
|
|
Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy
Week 24
|
1470 ng/mL
Standard Deviation 547
|
—
|
SECONDARY outcome
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24Population: Results were analyzed and reported only for participants in the safety population who had ETV pharmacokinetic data assessments available.
Outcome measures
| Measure |
ABI-H0731 + SOC ETV
n=13 Participants
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
n=12 Participants
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
|---|---|---|
|
Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy
Baseline (Day 1)
|
0.00325 ng/mL
Standard Deviation 0.0113
|
0 ng/mL
Standard Deviation 0
|
|
Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy
Week 2
|
0.432 ng/mL
Standard Deviation 0.126
|
0.497 ng/mL
Standard Deviation 0.473
|
|
Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy
Week 4
|
0.419 ng/mL
Standard Deviation 0.119
|
0.618 ng/mL
Standard Deviation 0.736
|
|
Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy
Week 12
|
0.378 ng/mL
Standard Deviation 0.149
|
0.666 ng/mL
Standard Deviation 0.766
|
|
Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy
Week 24
|
0.411 ng/mL
Standard Deviation 0.143
|
0.408 ng/mL
Standard Deviation 0.131
|
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, 24, and 28Population: 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 ETV
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo + SOC ETV
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ABI-H0731 + SOC ETV
n=13 participants at risk
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
|
Placebo + SOC ETV
n=12 participants at risk
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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.
SOC ETV: Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet: Participants will receive matching QD placebo tablets orally.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • Number of events 1 • Up to Week 36
Safety population
|
8.3%
1/12 • Number of events 2 • Up to Week 36
Safety population
|
|
Infections and infestations
Folliculitis
|
7.7%
1/13 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/12 • Up to Week 36
Safety population
|
|
Infections and infestations
Viral infection
|
0.00%
0/13 • Up to Week 36
Safety population
|
8.3%
1/12 • Number of events 1 • Up to Week 36
Safety population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
2/13 • Number of events 2 • Up to Week 36
Safety population
|
0.00%
0/12 • Up to Week 36
Safety population
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.7%
1/13 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/12 • Up to Week 36
Safety population
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/13 • Up to Week 36
Safety population
|
8.3%
1/12 • Number of events 1 • Up to Week 36
Safety population
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 1 • Up to Week 36
Safety population
|
16.7%
2/12 • Number of events 2 • Up to Week 36
Safety population
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/13 • Up to Week 36
Safety population
|
8.3%
1/12 • Number of events 1 • Up to Week 36
Safety population
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1 • Up to Week 36
Safety population
|
8.3%
1/12 • Number of events 1 • Up to Week 36
Safety population
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • Number of events 2 • Up to Week 36
Safety population
|
0.00%
0/12 • Up to Week 36
Safety population
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/13 • Up to Week 36
Safety population
|
8.3%
1/12 • Number of events 1 • Up to Week 36
Safety population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
1/13 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/12 • Up to Week 36
Safety population
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/12 • Up to Week 36
Safety population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/12 • Up to Week 36
Safety population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • Up to Week 36
Safety population
|
8.3%
1/12 • Number of events 1 • Up to Week 36
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • Up to Week 36
Safety population
|
8.3%
1/12 • Number of events 1 • Up to Week 36
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • Up to Week 36
Safety population
|
8.3%
1/12 • Number of events 1 • Up to Week 36
Safety population
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/12 • Up to Week 36
Safety population
|
|
Psychiatric disorders
Stress
|
0.00%
0/13 • Up to Week 36
Safety population
|
8.3%
1/12 • Number of events 1 • Up to Week 36
Safety population
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
7.7%
1/13 • Number of events 1 • Up to Week 36
Safety population
|
0.00%
0/12 • Up to Week 36
Safety population
|
Additional Information
Linda Baher, 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