Actively Recruiting
An Open-label, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of AHB-137 Injection in Adults With Chronic Hepatitis B Previously Treated With Nucleos(t)ide Analogues
Led by Ausper Biopharma Co., Ltd. · Updated on 2026-05-04
60
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of AHB-137 injection in adults with chronic hepatitis B (CHB) who have been previously treated with nucleos(t)ide analogues (NA). This open-label, phase II clinical trial is conducted across multiple centers and aims to evaluate how well the treatment controls the virus after stopping all other CHB treatments. Participants will receive injections of AHB-137 during the study. The trial does not include a placebo group and all participants will be monitored for response. The study will observe participants for up to 60 weeks, measuring viral markers and treatment effects over time. During the study, participants will undergo regular lab tests to check hepatitis B surface antigen (HBsAg), hepatitis B virus DNA, and other viral and immune markers. Researchers will also assess quality of life, detect any drug antibodies, and monitor safety through adverse event tracking. The main outcome is the proportion of participants who maintain very low or undetectable viral levels 24 weeks after stopping all CHB treatments.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate in the study and sign the informed consent form
- Be between 18 and 65 years old (including boundary ages)
- Have a body mass index that meets study requirements
- Have chronic hepatitis B infection with positive HBsAg or HBV DNA for at least 6 months
- Meet specific prior medication requirements
- Have HBsAg, HBV DNA, and liver function indicators within required limits
- Use effective contraception as required
You will not qualify if you...
- Have uncontrolled or unstable clinically significant abnormalities aside from chronic hepatitis B
- Have associated liver diseases other than CHB
- Have serious infections requiring intravenous anti-infective therapy aside from CHB
- Test positive for HCV RNA, HIV antibodies, or syphilis
- Have abnormal laboratory test results
- Have vascular inflammatory diseases
- Have abnormal QT interval corrected by Fridericia method
- Have a history or ongoing concerns of malignancy
- Have allergies or allergic constitution
- Have recent major trauma or surgery, or plan to have surgery
- Be currently in another clinical trial or have not completed required washout period
- Have used prohibited medications before or currently
- Be judged inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 weeks
Participants receive injections of AHB-137 as part of the study treatment for chronic hepatitis B.
Visit schedule as per treatment protocol
Duration - 24 weeks after treatment ends
Participants are monitored after discontinuation of treatment to assess efficacy and safety outcomes.
Visits during 24-week follow-up period
Trial Site Locations
Total: 1 location
1
AusperBio Investigational Site
Jilin City, Changchun, China
Actively Recruiting
Research Team
L
Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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