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)
A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 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 Virus Infection (B-SUPREME)
Aligos Therapeutics
200 participants
Jul 15, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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).
- HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
- HBsAg ≥LLOQ.
- 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).
Exclusion Criteria11
- 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
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Interventions
300 mg tablet
300 mg tablet
Locations(58)
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NCT06963710