RECRUITING

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)

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Conditions

Chronic Hepatitis B InfectionCapsid Assembly ModulatorsCAMsCHBHBVChronic Hepatitis BHepatitis B InfectionHepatitis B

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2025-07-15
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06963710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2.
  2. 2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
  3. 3. HBsAg ≥100 IU/mL.
  4. 4. HBV DNA ≥20,000 IU/mL.
  5. 5. A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.
  6. 6. Must have the following chronic hepatitis B virus infection treatment status at screening:
  7. 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
  8. 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).
  1. 1. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
  2. 2. Positive for anti-HBs antibodies.
  3. 3. History or current evidence of cirrhosis.
  4. 4. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
  5. 5. History of, or current evidence of, hepatic decompensation.
  6. 6. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
  7. 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. 8. Exclusionary screening laboratory values include:
  9. 1. Aspartate aminotransferase (AST) \>8×ULN,
  10. 2. Bilirubin (total, direct) \>1.2×ULN (unless Gilbert's syndrome is suspected)
  11. 3. International Normalization Ratio (INR) \>1.2×ULN

Contacts and Locations

Study Contact

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

Study Locations (Sites)

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
Rialto, California, 92377
United States
Aligos Investigational Site
San Jose, California, 95116
United States
Aligos Investigational Site
Chevy Chase, Maryland, 20815
United States

Collaborators and Investigators

Sponsor: Aligos Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-15
Study Completion Date2028-08

Study Record Updates

Study Start Date2025-07-15
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • Capsid Assembly Modulators
  • CAMs
  • CHB
  • HBV
  • Chronic Hepatitis B
  • Hepatitis B Infection
  • Hepatitis B

Additional Relevant MeSH Terms

  • Chronic Hepatitis B Infection