NCT03577171

A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)

A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Patients With Chronic Hepatitis B

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (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) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)

Detailed description

This is a Phase 2a, multi-center, double-blind, placebo-controlled study evaluating ABI-H0731+ ETV vs ETV alone for the treatment of viremic hepatitis B "e" antigen (HBeAg)-positive participants with cHBV.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	ABI-H0731	Participants will receive 300mg QD of ABI-H0731 tablets orally.
DRUG	SOC ETV	Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
DRUG	Placebo Oral Tablet	Participants will receive matching QD placebo tablets orally.

Timeline

• Start date: 2018-06-19
• Primary completion: 2019-06-21
• Completion: 2019-06-21
• First posted: 2018-07-05
• Last updated: 2021-01-28
• Results posted: 2021-01-28

Locations

12 sites across 5 countries: United States, Canada, Hong Kong, New Zealand, United Kingdom

Regulatory

• FDA-regulated drug study