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A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients

NCT03780543 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2023-04-19

Study results available
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Summary

Open-label, extension study to evaluate the safety and efficacy of combination therapy and its effect on sustained viral response biomarkers.

Conditions

Interventions

DRUG

standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)

Participants will continue on their SOC NrtI, Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) or Tenofovir Alafenamide (TAF) tablet QD (once daily) orally as per approved package insert.

Sponsors & Collaborators

  • Assembly Biosciences

    lead INDUSTRY

Principal Investigators

  • Michele Anderson · Assembly Biosciences Inc.

  • M. F. Yuen, MD, PhD, DSc · The University of Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2021-04-26
Completion
2021-04-26
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 NCT03780543 on ClinicalTrials.gov