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)

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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).

🚫 You may not be able to join if…

• 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

Where this trial is running

• Aligos Investigational Site, Chandler, Arizona, United States
• Aligos Investigational Site, Coronado, California, United States
• Aligos Investigational Site, Garden Grove, California, United States
• Aligos Investigational Site, Los Angeles, California, United States
• Aligos Investigational Site, Palo Alto, California, United States
• Aligos Investigational Site, Pasadena, California, United States
• Aligos Investigational Site, Rialto, California, United States
• Aligos Investigational Site, San Francisco, California, United States
• Aligos Investigational Site, San Jose, California, United States
• Aligos Investigational Site, Miami, Florida, United States
• Aligos Investigational Site, Miami, Florida, United States
• Aligos Investigational Site, Marrero, Louisiana, United States

+ 46 more sites.

Who to contact

Aligos Therapeutics · (800) 466-6059 · info@aligos.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06963710.