Actively Recruiting
ASC22 Combined With Peg-IFNa in Achieving Functional Cure in Patients With Chronic Hepatitis B Virus Infection
Led by The Second Affiliated Hospital of Chongqing Medical University · Updated on 2026-05-07
150
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
Sponsors
T
The Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor
F
First Affiliated Hospital of Chongqing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Exploring the safety and efficacy of the therapy combining immune checkpoint inhibitors (anti-PD-L1 monoclonal antibody, ASC22) and pegylated interferon alfa (Peg-IFNα) in patients with CHB. Exploring new combination therapeutic schemes for hepatitis B cure, and raising the overall clinical cure rate to more than 50% without screening specific advantageous groups.
CONDITIONS
Official Title
ASC22 Combined With Peg-IFNa in Achieving Functional Cure in Patients With Chronic Hepatitis B Virus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) of 18 to 32 kg/m²
- Serum HBsAg less than 100 IU/mL
- HBV DNA less than 20 IU/mL
- Hepatitis B e-antigen (HBeAg) negative
- Age between 18 and 70 years
You will not qualify if you...
- History or suspicion of allergy to the study drug or its ingredients
- Use of immunosuppressants, immunomodulators (thymosin), or cytotoxic drugs within 6 months before enrollment
- Vaccination with live attenuated vaccine within 1 month before enrollment
- Acute infection within 2 weeks before enrollment requiring intravenous antibiotics
- Current infection requiring anti-infection treatment at enrollment
- Confirmed or suspected decompensated cirrhosis
- Presence of malignant tumors
- Serious diseases affecting circulatory, respiratory, urinary, blood, metabolic, immune, mental, neurological, renal, or other systems
- Positive for hepatitis C virus antibody, HIV antigen/antibody, or syphilis tests
- Female participants who are breastfeeding or have a positive pregnancy test during screening
- Other factors deemed unsuitable for the study by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The 2nd affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Actively Recruiting
Research Team
D
Dachuan Cai, MD
CONTACT
M
Min Chen, PhD
CONTACT
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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