Trial Outcomes & Findings for A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors (NCT NCT04454567)
NCT ID: NCT04454567
Last Updated: 2022-10-20
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Baseline and up to 5 months
Results posted on
2022-10-20
Participant Flow
Participant milestones
| Measure |
ABI-H0731 + SOC NrtI
Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
Placebo + SOC NrtI
Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
ABI-H0731 + SOC NrtI
Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
Placebo + SOC NrtI
Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
1
|
1
|
Baseline Characteristics
A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
Baseline characteristics by cohort
| Measure |
ABI-H0731 + SOC NrtI
n=1 Participants
Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
Placebo + SOC NrtI
n=1 Participants
Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
0 Participants
n=7 Participants
|
0 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
Hong Kong
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Years positive for HBV
|
4.6 years
n=5 Participants
|
45 years
n=7 Participants
|
24.8 years
STANDARD_DEVIATION 28.567 • n=5 Participants
|
|
Years on HBV treatment at Baseline
|
3.6 years
n=5 Participants
|
1.5 years
n=7 Participants
|
2.55 years
STANDARD_DEVIATION 1.485 • n=5 Participants
|
|
Baseline HBV DNA (Cobas log10 IU/mL)
|
2.20 log10 IU/mL
n=5 Participants
|
2.06 log10 IU/mL
n=7 Participants
|
2.13 log10 IU/mL
STANDARD_DEVIATION 0.099 • n=5 Participants
|
|
Baseline HBV pgRNA (log10 U/mL)
|
4.85 log10 U/mL
n=5 Participants
|
6.55 log10 U/mL
n=7 Participants
|
5.7 log10 U/mL
STANDARD_DEVIATION 1.202 • n=5 Participants
|
|
Baseline HBeAg (log10 IU/mL)
|
2.35 log10 IU/mL
n=5 Participants
|
2.82 log10 IU/mL
n=7 Participants
|
2.585 log10 IU/mL
STANDARD_DEVIATION 0.332 • n=5 Participants
|
|
Baseline HBcrAg (log10 kU/mL)
|
0.89 log10 kU/mL
n=5 Participants
|
0.92 log10 kU/mL
n=7 Participants
|
0.905 log10 kU/mL
STANDARD_DEVIATION 0.021 • n=5 Participants
|
|
Baseline HBsAg (log10 IU/mL)
|
3.81 log10 IU/mL
n=5 Participants
|
4.61 log10 IU/mL
n=7 Participants
|
4.21 log10 IU/mL
STANDARD_DEVIATION 0.566 • n=5 Participants
|
|
Baseline ALT (U/L)
|
16 U/L
n=5 Participants
|
11 U/L
n=7 Participants
|
13.5 U/L
STANDARD_DEVIATION 3.536 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 5 monthsOutcome measures
| Measure |
ABI-H0731 + SOC NrtI
n=1 Participants
Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
Placebo + SOC NrtI
n=1 Participants
Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
|---|---|---|
|
Number of Participants With an Adverse Event
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline and up to 5 monthsOutcome measures
| Measure |
ABI-H0731 + SOC NrtI
n=1 Participants
Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
Placebo + SOC NrtI
n=1 Participants
Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
|---|---|---|
|
Number of Participants With Premature Discontinuation of Treatment
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline and up to 5 monthsOutcome measures
| Measure |
ABI-H0731 + SOC NrtI
n=1 Participants
Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
Placebo + SOC NrtI
n=1 Participants
Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
|---|---|---|
|
Number of Participants With a Laboratory Abnormality
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Week 48Population: Due to early termination of the study, data for Week 48 were not collected and analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 5 monthsPopulation: Due to early termination of the study, data were not collected and analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 5 monthsPopulation: Due to early termination of the study, data were not available to analyze the secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 5 monthsPopulation: Due to early termination of the study, data were not analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 5 monthsPopulation: Due to early termination of the study, data were not analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 5 monthsPopulation: Due to early termination of the study, data were not analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 5 monthsPopulation: Due to early termination of the study, data were not analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 5 monthsPopulation: Due to early termination of the study, data were not analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 5 monthsPopulation: Due to early termination of the study, data were not analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 5 monthsPopulation: Due to early termination of the study, data were not analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 5 monthsPopulation: Due to early termination of the study, data were not analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 5 monthsPopulation: Due to early termination of the study, data were not analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and up to 5 monthsPopulation: Due to early termination of the study, data were not analyzed for secondary outcomes.
Outcome measures
Outcome data not reported
Adverse Events
ABI-H0731 + SOC NrtI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo + SOC NrtI
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ABI-H0731 + SOC NrtI
n=1 participants at risk
Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
Placebo + SOC NrtI
n=1 participants at risk
Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Baseline and up to 5 months
|
100.0%
1/1 • Number of events 1 • Baseline and up to 5 months
|
|
Injury, poisoning and procedural complications
Flu like symptoms
|
0.00%
0/1 • Baseline and up to 5 months
|
100.0%
1/1 • Number of events 1 • Baseline and up to 5 months
|
Additional Information
Executive Director of Clinical Operations
Assembly Biosciences
Phone: 833-509-4583
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