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)

Korábbi kezelés

• Positive for anti-HBs antibodies.
• 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

Más betegség

• Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
• Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
• History of, or current evidence of, hepatic decompensation.

Laborértékek

• 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

Egyéb

• History or current evidence of cirrhosis.
• Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.

• 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).