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
N/A
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
Researchers are evaluating the safety and effectiveness of combining immune checkpoint inhibitors (specifically the anti-PD-L1 monoclonal antibody ASC22) with pegylated interferon alfa (Peg-IFN) to treat patients with chronic hepatitis B (CHB). The study aims to explore new combination treatments to improve the cure rate for hepatitis B to over 50%, without selecting only specific patient groups. This is a Phase 4 interventional trial sponsored by The Second Affiliated Hospital of Chongqing Medical University. Participants will be assigned randomly to one of five treatment groups. These groups involve different combinations and schedules of anti-PD-L1 antibody (ASC22) given every two weeks by injection, pegylated interferon alfa administered weekly by injection, and daily oral nucleotide analogs. Treatments last from 24 to 48 weeks depending on the group. For example, some groups receive ASC22 for the first 24 weeks combined with nucleotide analogs, followed by Peg-IFN with ASC22 or nucleotide analogs in the second 24 weeks. Another group receives Peg-IFN with nucleotide analogs for 48 weeks, while one group receives only nucleotide analogs. During the study, participants will have their blood tested at the start, during treatment at 24 and 48 weeks, and 24 weeks after treatment ends. Tests include measuring hepatitis B surface antigen (HBsAg), hepatitis B virus DNA levels, and liver enzyme alanine aminotransferase (ALT). These measures help assess the virus activity and liver health. The total participation time depends on the treatment group but includes follow-up 24 weeks after therapy completion to monitor outcomes and safety.
CONDITIONS
Brief 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/m^2
- Serum hepatitis B surface antigen (HBsAg) less than 100 IU/mL
- Hepatitis B virus (HBV) DNA less than 20 IU/mL
- Hepatitis B e antigen (HBeAg) negative
- Adults aged between 18 and 70 years
You will not qualify if you...
- History of allergy or suspected allergy to study drugs or their 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 or current infection needing treatment
- Confirmed or suspected decompensated liver cirrhosis
- Presence of malignant tumors
- Serious diseases affecting circulatory, respiratory, urinary, blood, metabolic, immune, mental, neurological, renal, or other systems
- Positive tests for hepatitis C virus (HCV), HIV, or syphilis
- Female participants who are breastfeeding or have a positive pregnancy test during screening
- Other factors deemed unsuitable by the researcher
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 48 weeks depending on cohort
Participants receive different combinations of Anti-PD-L1 antibody (ASC22), Peg-IFNα, and nucleotide analogs depending on their assigned cohort.
Weekly or biweekly visits depending on treatment schedule for up to 48 weeks
Duration - 24 weeks after treatment ends
Participants are monitored for 24 weeks after the end of treatment to assess the sustained effects of the interventions.
Visits at 24 weeks after treatment completion
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
M
Min Chen, PhD
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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