Health Trials

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)

ConditionChronic Hepatitis B Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAligos Therapeutics

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.

Positive for anti-HBs antibodies.

History or current evidence of cirrhosis.

Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.

Trial design

Treatments tested in this trial

  • ALG-000184
  • TDF

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Aligos Therapeutics

Lead sponsor

Source ClinicalTrials.gov