Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Jennifer Price
Headshot of Jennifer Price
Jennifer Price

Description

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.

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)

Details

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.

Keywords

Chronic Hepatitis B Infection, Capsid Assembly Modulators, CAMs, CHB, HBV, Chronic Hepatitis B, Hepatitis B Infection, Hepatitis B, ALG-000184, TDF

Eligibility

You can join if…

Open to people ages 18-65

  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).

You CAN'T join if...

  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

  • Aligos Investigational Site
    San Francisco California 94117 United States
  • Aligos Investigational Site
    San Jose California 95116 United States

Lead Scientist at UCSF

  • Jennifer Price
    Professor, Medicine, School of Medicine. Authored (or co-authored) 145 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aligos Therapeutics
ID
NCT06963710
Phase
Phase 2 Hepatitis B Research Study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated