Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAusperBio Therapeutics Inc.

About this trial

This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with CHB treated with Nucleos(t)ide Analogue (NAs).

Eligibility criteria

Qualifiers

Adults ≥18 years of age and up to 65 years of age (inclusive) at Screening who are able to provide informed consent, comply with study procedures, and agree to discontinue nucleos(t)ide analog (NA) therapy if protocol-defined discontinuation criteria are met.

Body mass index (BMI) ≤35 kg/m².

Documented chronic hepatitis B virus (HBV) infection for ≥6 months prior to randomization, defined by hepatitis B surface antigen (HBsAg) positivity or detectable HBV DNA.

Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.

Disqualifiers

Clinically significant disease other than chronic hepatitis B virus (HBV) infection.

Concomitant clinically significant liver disease.

Any severe infection (other than chronic HBV infection) within 1 month prior to randomization.

History of immune thrombocytopenia.

Trial design

Treatments tested in this trial

  • AHB-137

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators