NCT04820686

A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection

A Randomized Phase 2a, Multicenter, Open-Label, Multiple-Cohort Study Evaluating Regimens Containing Vebicorvir in Subjects With Chronic Hepatitis B Virus Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Assembly Biosciences · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The initial cohort of participants will be enrolled in 3 treatment groups receiving 1) VBR + AB-729 + SOC NrtI, 2) VBR + SOC NrtI, or 3) AB-729 + SOC NrtI for up to 48 weeks. At Week 48, all participants will have an assessment of Treatment Stopping Criteria. Any participant who meets the Treatment Stopping Criteria, will discontinue their assigned treatment including NrtI and will remain in follow-up through Week 96. The participants who do not meet the Treatment Stopping Criteria will continue treatment with NrtI alone and will remain in follow-up through Week 96. Up to an additional 2 cohorts may be added to the study in future protocol amendments.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-07
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2021-03-29
• Last updated: 2023-11-14
• Results posted: 2023-11-14

Locations

20 sites across 4 countries: Australia, Bulgaria, Canada, New Zealand

Regulatory

• FDA-regulated drug study