Back to Trials
NCT06963710PHASE2Recruiting

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)

Aligos Therapeutics

Start Date

7/15/2025

Completion Date

8/1/2028

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 treatment naive (TN) or currently not treated (CNT) HBeAg-positive and HBeAg-negative subjects with chronic HBV infection (inclusive of chronic infection and/or chronic hepatitis). A total of approximately 200 eligible subjects will be enrolled across 2 study parts. Part 1 will be an evaluation of HBeAg-positive subjects with chronic HBV infection and Part 2 will be an evaluation of HBeAg-negative subjects with chronic HBV infection. Each study part will consist of a main study and an exploratory liver biopsy sub-study. Following the 48-week double-blind dosing period (Week 48), all participating subjects (in Parts 1 and 2) will be allowed to roll over into a 48 week (i.e., Week 48-96) open-label treatment extension period where they will all receive ALG-000184 monotherapy.

Eligibility Criteria

Age Range: 18 years to 65 years

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

Interventions

DRUG

ALG-000184

DRUG

TDF

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Chronic Hepatitis B Infection

Locations

Aligos Investigational Site

Chandler, Arizona 85224

United States

Aligos Investigational Site

Coronado, California 92118

United States

Aligos Investigational Site

Garden Grove, California 92840

United States

Aligos Investigational Site

Los Angeles, California 90033

United States

Aligos Investigational Site

Palo Alto, California 94304

United States

Aligos Investigational Site

Pasadena, California 91105

United States

Aligos Investigational Site

Rialto, California 92377

United States

Aligos Investigational Site

San Francisco, California 94117

United States

Aligos Investigational Site

San Jose, California 95116

United States

Aligos Investigational Site

Miami, Florida 33136

United States

Aligos Investigational Site

Miami, Florida 33173

United States

Aligos Investigational Site

Marrero, Louisiana 70072

United States

Aligos Investigational Site

Baltimore, Maryland 21287

United States

Aligos Investigational Site

Chevy Chase, Maryland 20815

United States

Aligos Investigational Site

Boston, Massachusetts 02114

United States

Aligos Investigational Site

Manhasset, New York 10075

United States

Aligos Investigational Site

New York, New York 10016

United States

Aligos Investigational Site

Durham, North Carolina 27710

United States

Aligos Investigational Site

Sliven,

Bulgaria

Aligos Investigational Sites

Sofia,

Bulgaria

Aligos Investigational Site

Stara Zagora,

Bulgaria

Aligos Investigational Site

Edmonton,

Canada

Aligos Investigational Site

Ottawa,

Canada

Aligos Investigational Site

Toronto,

Canada

Aligos Investigational Sites

Vancouver,

Canada

Aligos Investigational Sites

Beijing,

China

Aligos Investigational Site

Changchun,

China

Aligos Investigational Site

Chengdu,

China

Aligos Investigational Site

Chongqing,

China

Aligos Investigational Sites

Guangzhou,

China

Aligos Investigational Site

Nanjing,

China

Aligos Investigational Sites

Shanghai,

China

Aligos Investigational Site

Clichy,

France

Aligos Investigational Site

Limoges,

France

Aligos Investigational Site

Nice,

France

Aligos Investigational Site

Rennes,

France

Aligos Investigational Site

Rouen,

France

Aligos Investigational Site

Toulouse,

France

Aligos Investigational Sites

Hong Kong,

Hong Kong

Aligos Investigational Site

Milan,

Italy

Aligos Investigational Site

Chisinau,

Moldova

Aligos Investigational Site

Auckland,

New Zealand

Aligos Investigational Sites

Bucharest,

Romania

Aligos Investigational Site

Ansan,

South Korea

Aligos Investigational Site

Busan,

South Korea

Aligos Investigational Sites

Seoul,

South Korea

Aligos Investigational Site

Ulsan,

South Korea

Aligos Investigational Site

Yangsan,

South Korea

Aligos Investigational Site

Barcelona,

Spain

Aligos Investigational Site

Pontevedra,

Spain

Aligos Investigational Site

Chiayi City,

Taiwan

Aligos Investigational Site

Kaohsiung City,

Taiwan

Aligos Investigational Site

Taichung,

Taiwan

Aligos Investigational Site

Tainan,

Taiwan

Aligos Investigational Site

Taipei,

Taiwan

Aligos Investigational Site

Glasgow,

United Kingdom

Aligos Investigational Site

Leicester,

United Kingdom

Aligos Investigational Sites

London,

United Kingdom