A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection
NCT04820686 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2023-11-14
Summary
The purpose of this study is to determine if vebicorvir (VBR, ABI-H0731) in combination with AB-729 is safe and effective in participants with chronic hepatitis B infection (cHBV) receiving a standard of care nucleos(t)ide/reverse transcriptase inhibitor (SOC NrtI).
Conditions
Interventions
- DRUG
-
VBR
VBR is an HBV core protein inhibitor. Participants will receive VBR 300 mg tablets orally once daily (QD).
- DRUG
-
AB-729
AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants will receive a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
- DRUG
-
SOC NrtI
Participants will receive their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
Sponsors & Collaborators
-
Arbutus Biopharma Corporation
collaborator INDUSTRY -
Assembly Biosciences
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-07
- Primary Completion
- 2023-03-30
- Completion
- 2023-03-30
- FDA Drug
- Yes
Countries
- Australia
- Bulgaria
- Canada
- New Zealand
Study Locations
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