RecruitingHepatitis B, Chronic
Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
Eligible age
18–65 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: AusperBio Therapeutics Inc.
You may qualify if…
- ✓ Participants are eligible to be included in the study only if all of the following criteria apply:
- ✓ 1. 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.
- ✓ 2. Body mass index (BMI) ≤35 kg/m².
- ✓ 3. 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.
- ✓ 4. Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.
- ✓ 5. HBV DNA meeting protocol-specified virologic criteria at Screening.
- ✓ 6. Hepatitis B surface antigen (HBsAg) level meeting protocol-specified virologic criteria at Screening.
- ✓ 7. Alanine aminotransferase (ALT) meeting protocol-specified criteria at Screening.
You may not qualify if…
- ✕ Participants will be excluded from the study if any of the following criteria apply:
- ✕ 1. Clinically significant disease other than chronic hepatitis B virus (HBV) infection.
- ✕ 2. Concomitant clinically significant liver disease.
- ✕ 3. Any severe infection (other than chronic HBV infection) within 1 month prior to randomization.
- ✕ 4. History of immune thrombocytopenia.
- ✕ 5. Current suspected liver cirrhosis and/or evidence of cirrhosis by protocol-specified criteria for FibroScan® or equivalent imaging modality (e.g., ultrasound elastography); historical FibroScan® (or equivalent) results with documentation within 6 months from screening is acceptable.
- ✕ 6. History of liver cirrhosis defined by liver biopsy or by FibroScan® or equivalent imaging modality using protocol-specified criteria.
- ✕ 7. Prior history of, current diagnosis of, or suspected hepatocellular carcinoma (HCC), or alpha-fetoprotein (AFP) ≥20 ng/mL at Screening.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07654283 · last updated 2026-08-06