Actively Recruiting
A Randomized, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AHB-137 Injection Combined With Hepatitis B Vaccine or Pegylated Interferon α-2b in Adults With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Analogues
Led by Ausper Biopharma Co., Ltd. · Updated on 2026-05-20
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of AHB-137 injection combined with other hepatitis B treatments in adults aged 18 to 65 who have HBeAg-negative chronic hepatitis B and are already treated with nucleoside or nucleotide analogues. This phase II, randomized, open-label, multicenter study aims to understand how well this combination controls the virus and improves patient outcomes. The study is sponsored by Ausper Biopharma Co., Ltd. Participants will receive AHB-137 injections combined with either pegylated interferon alpha-2b (Peg-IFN), hepatitis B vaccine, or both, in various treatment durations up to 24 weeks depending on the study group. The study includes multiple experimental groups receiving different combinations and durations of these treatments to evaluate their combined effects. Treatment effects and safety will be monitored during and after therapy. During the study, participants will have regular assessments including blood tests to measure hepatitis B virus markers like HBsAg, HBV DNA, and others, liver enzyme levels, and immune responses. Researchers will also track quality of life, depressive symptoms, and possible adverse events up to 72 weeks. The primary goal is to observe the proportion of participants achieving viral suppression after stopping all treatment, with follow-up visits to monitor relapse and safety. Total participation duration may extend up to 72 weeks post-treatment.
CONDITIONS
Brief Title
A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants voluntarily agree and sign informed consent before screening
- Aged between 18 and 65 years at consent
- Body mass index (BMI) between 18 and 30 kg/m2
- HBeAg negative at screening
- HBsAg or HBV DNA positive for at least 6 months
- On antiviral therapy with a single nucleoside or nucleotide analogue for more than 6 months before screening
- Alanine aminotransferase (ALT) level less than or equal to twice the upper limit of normal
- Use effective contraception as required
You will not qualify if you...
- Not eligible for treatment with pegylated interferon or hepatitis B vaccine
- Significant abnormalities beyond chronic hepatitis B history
- Other clinically significant liver diseases
- Serious infections needing intravenous treatment within 1 month before screening
- Positive for HCV RNA, HIV, or syphilis
- Significant liver fibrosis or cirrhosis, or liver stiffness above 9.0 kPa
- History or signs of hepatic decompensation
- Diagnosis or suspicion of liver cancer or alpha-fetoprotein level 20 ng/mL or higher
- Abnormal laboratory test results
- History or signs of vasculitis or related diseases
- Abnormal corrected QT interval on ECG
- History of extrahepatic disease possibly linked to HBV immune status
- History of cancer within 5 years or being evaluated for cancer
- Serious mental illness history
- Allergic reaction history to study drugs
- Major surgery or trauma within 3 months prior or planned during study
- Participation in another clinical trial without required washout
- Use of immunosuppressive drugs within 3 months, except short courses or topical/inhaled steroids
- Use of immunomodulators or cytotoxic drugs within 6 months before first dose
- Vaccination within 6 months before screening or planned live vaccination during trial
- Need for regular long-term blood thinners
- Thyroid dysfunction
- Uncontrolled epilepsy or progressive neurological disorders
- Prior treatment with antisense oligonucleotides or small interfering RNA drugs
- Any other condition deemed inappropriate by investigators
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 - 16 to 24 weeks depending on treatment group
Participants receive AHB-137 injection combined with Pegylated Interferon α-2b or Hepatitis B vaccine along with nucleos(t)ide analogues to treat chronic hepatitis B.
Weekly visits during treatment period
Duration - Up to 72 weeks after treatment completion
Participants are monitored after all treatment has ended to assess the persistence of viral suppression and safety outcomes.
Periodic visits for assessments up to 72 weeks
Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
L
Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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