ClinicaliQ Trial Snapshot
- Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions — Recruiting • Phase II • Gastroenterology • NCT07654283.
- What is being tested: AHB-137 injection is being evaluated as an add-on therapy to existing Nucleos(t)ide Analogue treatment in a phase 2 randomised controlled trial, assessing both efficacy and safety outcomes in chronic hepatitis B patients.
- Patient eligibility: The trial targets adults with chronic hepatitis B who are already receiving established Nucleos(t)ide Analogue therapy across North American and European centres, representing a well-defined patient population with diagnosed CHB.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : Participants are eligible to be included in the study only if all of the following criteria apply:
- 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. 8. Screening electrocardiogram (ECG) without clinically significant abnormalities and with a Fridericia-corrected QT interval (QTcF) ≤450 msec for males or ≤470 msec for females. 9. Females of childbearing potential must not be breastfeeding and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to first dose. 10. Males and female participants of childbearing potential must…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.