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A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection

NCT04398134 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2022-09-15

Study results available
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Summary

This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK) of ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir (ETV) in participants with chronic hepatitis B virus (HBV) infection.

Conditions

Interventions

DRUG

ABI-H2158

3 X 100 mg tablets for oral administration

DRUG

Placebo

Sugar pill manufactured to mimic the ABI-H2158 tablets

DRUG

Entecavir (ETV)

0.5 mg tablet for oral administration

Sponsors & Collaborators

  • Assembly Biosciences

    lead INDUSTRY

Principal Investigators

  • Grace Wang · Assembly Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-08-28
Primary Completion
2021-10-14
Completion
2021-12-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • Hong Kong
  • New Zealand
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT04398134 on ClinicalTrials.gov