Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific… (NCT07370207) | Clinical Trial Compass
RecruitingPhase 2
Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region
Australia, China, New Zealand84 participantsStarted 2026-03-06
Plain-language summary
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 HBeAg-negative CHB treated with NAs.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Adults ≥18 years of age (or per local age of majority) and ≤65 years of age 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.
✓. Hepatitis B e antigen (HBeAg) negative at Screening.
✓. Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.
✓. HBV DNA below the lower limit of quantification (LLOQ) at Screening.
✓. Hepatitis B surface antigen (HBsAg) level \>100 IU/mL and ≤3,000 IU/mL at Screening.
✓. Alanine aminotransferase (ALT) ≤2 × upper limit of normal (ULN) at Screening.
Exclusion criteria
✕. Clinically significant disease other than chronic hepatitis B virus (HBV) infection, as documented in medical history or identified on physical examination, including but not limited to acute coronary syndrome within 6 months prior to Screening, significant or unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy, or prior solid organ or bone marrow transplant
✕. Concomitant clinically significant liver disease, including but not limited to viral hepatitis caused by other pathogens, hemochromatosis, Wilson's disease, primary biliary cholangitis, autoimmune liver disease, alcoholic liver disease, drug-induced liver injury, or current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, hepatorenal syndrome, or variceal hemorrhage).
What they're measuring
1
Proportion of participants with sustained response post AHB-137 treatment
✕. Any severe infection (other than chronic HBV infection) within 1 month prior to randomization and/or requiring intravenous anti-infective therapy.
✕. History of immune thrombocytopenia.
✕. Current suspected liver cirrhosis and/or evidence of cirrhosis defined as liver stiffness measurement (LSM) \>9 kPa by FibroScan® or equivalent imaging modality (e.g., ultrasound elastography).
✕. History of liver cirrhosis defined by liver biopsy or by LSM \>12 kPa by FibroScan® or equivalent imaging modality.
✕. Prior history of, current diagnosis of, or suspected hepatocellular carcinoma (HCC), or alpha-fetoprotein (AFP) ≥20 ng/mL at Screening.
✕. History of extrahepatic diseases potentially associated with HBV infection, including but not limited to nephrotic syndrome, any form of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, or uncontrolled hypertension.