MedTrace Logo

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

NCT03577171 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-01-28

Study results available
· View outcomes & findings →

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)

Conditions

Interventions

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.

Sponsors & Collaborators

  • Assembly Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2019-06-21
Completion
2019-06-21
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Hong Kong
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03577171 on ClinicalTrials.gov