A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors

NCT04454567 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-10-20

Study results available
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Summary

This study will explore the safety and antiviral activity of ABI-H0731 when added to a nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially virologically suppressed.

Conditions

Interventions

DRUG

ABI-H0731

Participants will receive ABI-H0731 tablets orally once daily

DRUG

Placebo

Participants will receive placebo to ABI-H0731 tablets orally once daily

DRUG

NrtI

Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert

Sponsors & Collaborators

  • Assembly Biosciences

    lead INDUSTRY

Principal Investigators

  • Steven Knox · 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
2020-11-11
Primary Completion
2021-04-08
Completion
2021-04-08
FDA Drug
Yes

Countries

  • United States
  • Hong Kong
  • New Zealand

Study Locations

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Entities

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 NCT04454567 on ClinicalTrials.gov