A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
NCT04454567 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2022-10-20
Summary
This study will explore the safety and antiviral activity of ABI-H0731 when added to a nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially virologically suppressed.
Conditions
Interventions
- DRUG
-
ABI-H0731
Participants will receive ABI-H0731 tablets orally once daily
- DRUG
-
Participants will receive placebo to ABI-H0731 tablets orally once daily
- DRUG
-
NrtI
Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
Sponsors & Collaborators
-
Assembly Biosciences
lead INDUSTRY
Principal Investigators
-
Steven Knox · Assembly Biosciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-11
- Primary Completion
- 2021-04-08
- Completion
- 2021-04-08
- FDA Drug
- Yes
Countries
- United States
- Hong Kong
- New Zealand
Study Locations
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