CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
ABI-H0731 +2 moredrug
Likely dose
ABI-H0731 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03576066
NCT03576066Phase 2Completed
CompareCT.gov

A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Patients With Chronic Hepatitis B

Assembly Biosciences·interventional·Posted Jul 3, 2018·Updated Feb 17, 2021

In Brief

A Phase 2 clinical trial evaluating ABI-H0731, SOC NUC, and 1 other intervention for Chronic Hepatitis B. Completed, enrolled 73 participants across 21 sites in 3 countries.

Detailed Summary

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC) medication is safe and effective in participants with chronic hepatitis B virus infection (cHBV).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesCanada, New Zealand, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 3, 2018
Enrollment StartJun 11, 2018
Primary CompletionJul 5, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.0 years ago

Interventions

ABI-H0731drug

Participants will receive ABI-H0731 300 mg tablets orally once daily (QD).

SOC NUCdrug

Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.

Placebo Oral Tabletdrug

Participants will receive placebo matching ABI-0731 tablets orally QD.