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

NCT03576066 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2021-02-17

Study results available
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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).

Conditions

Interventions

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.

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
2018-06-11
Primary Completion
2019-07-05
Completion
2019-07-05
FDA Drug
Yes

Countries

  • United States
  • Canada
  • New Zealand

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 NCT03576066 on ClinicalTrials.gov