Status:

RECRUITING

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)

Lead Sponsor:

Aligos Therapeutics

Conditions:

Chronic Hepatitis B Infection

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief 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.

Detailed Description

This is a randomized, double-blind, active-controlled, multicenter Phase 2 study to evaluate the efficacy and safety of 48 weeks of oral (PO) once daily (QD) monotherapy with ALG-000184 versus TDF in ...

Eligibility Criteria

Key Inclusion Criteria:

  1. Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2 (or minimun age by local regulatory requirements).

  2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).

  3. HBsAg ≥LLOQ.

  4. HBV DNA ≥20,000 IU/mL.

  5. A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.

  6. Must have the following chronic hepatitis B virus infection treatment status at screening:

    1. Have never received treatment with HBV antiviral medicines (NA, interferon) or investigational anti-HBV agents including a CAM [i.e., Treatment Naïve (TN) subjects], OR
    2. Have not been on treatment with approved (NA, interferon) or investigational HBV antiviral medicines (e.g., antisense oligonucleotides or small interfering RNAs) within 6 months or 5 half-lives (whichever is longer) prior to randomization (i.e., Currently Not Treated (CNT) subjects).

Key Exclusion Criteria:

  1. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.

  2. Positive for anti-HBs antibodies.

  3. History or current evidence of cirrhosis.

  4. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.

  5. History of, or current evidence of, hepatic decompensation.

  6. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.

  7. Having received an investigational medicinal product or device within 4 weeks (or 5 half-lives, whichever is longer) before the planned first dose of study drug

  8. Exclusionary screening laboratory values include:

    1. Aspartate aminotransferase (AST) >8×ULN,
    2. Bilirubin (total, direct) >1.2×ULN (unless Gilbert's syndrome is suspected)
    3. International Normalization Ratio (INR) >1.2×ULN

Key Trial Info

Start Date :

July 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2028

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06963710

Start Date

July 15 2025

End Date

August 1 2028

Last Update

February 6 2026

Active Locations (57)

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Page 1 of 15 (57 locations)

1

Aligos Investigational Site

Chandler, Arizona, United States, 85224

2

Aligos Investigational Site

Coronado, California, United States, 92118

3

Aligos Investigational Site

Garden Grove, California, United States, 92840

4

Aligos Investigational Site

Los Angeles, California, United States, 90033