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
Inclusion
- Key
- Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2.
- HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
- HBsAg ≥100 IU/mL.
- HBV DNA ≥20,000 IU/mL.
- A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.
- Must have the following chronic hepatitis B virus infection treatment status at screening:
- 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
- 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
- Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
- Positive for anti-HBs antibodies.
- History or current evidence of cirrhosis.
- Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
- History of, or current evidence of, hepatic decompensation.
- Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
- 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
- Exclusionary screening laboratory values include:
- Aspartate aminotransferase (AST) \>8×ULN,
- Bilirubin (total, direct) \>1.2×ULN (unless Gilbert's syndrome is suspected)
- 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
November 6 2025
Active Locations (40)
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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