NCT03576066

A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Assembly Biosciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Participants with cHBV.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	ABI-H0731	Participants will receive ABI-H0731 300 mg tablets orally once daily (QD).
DRUG	SOC NUC	Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
DRUG	Placebo Oral Tablet	Participants will receive placebo matching ABI-0731 tablets orally QD.

Timeline

• Start date: 2018-06-11
• Primary completion: 2019-07-05
• Completion: 2019-07-05
• First posted: 2018-07-03
• Last updated: 2021-02-17
• Results posted: 2021-01-28

Locations

21 sites across 3 countries: United States, Canada, New Zealand

Regulatory

• FDA-regulated drug study