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

ConditionHepatitis B, Chronic
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • AHB-137

    Drug

    Subcutaneous injection

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Arm A: Dose Regimen AExperimental treatment 1 intervention
Group B: Arm B: Dose Regimen BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ)

Time frame
24 Weeks post AHB-137 treatment (Week 48)

Secondary outcomes

1

Proportion of participants with HBsAg < LOD and HBV DNA < LLOQ

Time frame
Off-treatment follow-up (Week 48 to 72)
2

Proportion of participants with HBsAg < LOD

Time frame
Week 72
3

Proportion of participants with HBV DNA < LLOQ

Time frame
From baseline through Week 72
4

Proportion of participants with protocol-defined virologic response for HBsAg and HBV DNA post AHB-137 treatment

Time frame
24 weeks post AHB-137 treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AusperBio Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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