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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)

NCT06963710

Active Not RecruitingPhase 2

Sponsor: Aligos Therapeutics

Conditions: Chronic Hepatitis B Infection

Interventions: ALG-000184, TDF

Countries: United States, Bulgaria, Canada, China, France, Hong Kong, Italy, Moldova

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (58)

Chandler, Arizona, United States
Coronado, California, United States
Garden Grove, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Pasadena, California, United States
Rialto, California, United States
San Francisco, California, United States
San Jose, California, United States
Miami, Florida, United States
Miami, Florida, United States
Marrero, Louisiana, United States
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
Boston, Massachusetts, United States
Manhasset, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Sliven, Bulgaria
Sofia, Bulgaria
Stara Zagora, Bulgaria
Edmonton, Canada
Ottawa, Canada
Toronto, Canada
Vancouver, Canada
Beijing, China
Changchun, China
Chengdu, China
Chongqing, China
Guangzhou, China
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