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A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)

NCT06963710 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-01

No results posted yet for this study

Summary

This is a Phase 2 study to evaluate efficacy and safety of 48 weeks of oral once daily monotherapy with ALG-000184 versus tenofovir disproxil fumarate (TDF) for chronic HBV infection.

Conditions

  • Chronic Hepatitis B Infection

Interventions

DRUG

ALG-000184

300 mg tablet

DRUG

TDF

300 mg tablet

Sponsors & Collaborators

  • Aligos Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2027-03-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • China
  • France
  • Hong Kong
  • Italy
  • Moldova
  • New Zealand
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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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 NCT06963710 on ClinicalTrials.gov