Actively Recruiting
A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (B)
Led by The Second Affiliated Hospital of Chongqing Medical University · Updated on 2025-09-11
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor
T
The Affiliated Hospital Of Southwest Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic Hepatitis B virus (HBV) infection is a significant public health issue in China. Current treatments with interferon alpha (IFNb1) or nucleos(t)ide analogues (NAs) achieve sustained loss of Hepatitis B surface antigen (HBsAg) in less than 10% of patients. Previous research increased this rate to 15% overall and up to 30-50% in patients with lower HBsAg levels using a sequential combination therapy. This trial aims to further improve this functional cure rate by combining immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway with IFNb1 to restore T cell function and enhance immune control against HBV. Participants will receive one of two treatment combinations: NAs plus anti-PD-1 antibody with Peg-IFNb1, or NAs plus Peg-IFNb1 alone. The anti-PD-1 antibody is administered subcutaneously or intravenously at intervals of one to three weeks at doses lower than those used for cancer. NAs are taken orally once daily, and Peg-IFNb1 is given as a weekly subcutaneous injection. This large multicenter prospective study will evaluate safety, efficacy, and rates of HBsAg loss compared to previous studies. During the study, participants will undergo regular assessments including blood tests for HBsAg, HBV DNA levels, and liver enzyme alanine aminotransferase (ALT) at baseline, 24 weeks, 48 weeks, and 24 weeks after treatment ends. Researchers will monitor immune response and safety throughout the trial. The study duration and follow-up will allow evaluation of long-term effects and the potential for a clinical cure to reduce the burden of HBV infection toward global elimination goals by 2030.
CONDITIONS
Brief Title
A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (B)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to complete the study as required
- Willingness to use effective contraception from inclusion to 30 days after last study drug dose if of childbearing potential
- Age 18 to 70 years; males weigh at least 45 kg, females at least 40 kg; BMI between 18 and 32 kg/m2
- Diagnosed with chronic hepatitis B and either naive or experienced with nucleos(t)ide analogues (NAs)
You will not qualify if you...
- History or suspicion of allergy to study drug or its components
- Use of CYP3A4 inhibitors, inducers, or substrates within 28 days before enrollment
- Use of immunosuppressants, immunomodulators, cytotoxic drugs within 6 months or live vaccine within 1 month before enrollment
- Acute infections requiring intravenous antibiotics within 2 weeks or ongoing infection needing treatment
- Significant liver diseases not caused by HBV
- Decompensated cirrhosis or progressive liver fibrosis
- Primary liver cancer or other malignancies within 5 years unless fully treated and stable
- History of pathological fracture or osteoporosis
- Gastrointestinal diseases affecting oral drug absorption or persistent severe symptoms
- Serious diseases of various major organ systems
- Major trauma or surgery within 3 months or planned surgery during study
- Recent blood donation or transfusion exceeding specified volumes
- Low blood cell counts, abnormal liver or kidney function tests
- Positive tests for hepatitis C, HIV, or syphilis
- Recent history of alcohol abuse or drug dependence
- Participation in other clinical trials with investigational drugs or devices within 3 months
- Pregnancy or breastfeeding
- Other factors deemed unsuitable by researchers
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive a combination of drugs including Anti-PD-1 antibody, NAs, and Peg-IFNα or NAs combined with Peg-IFNα to treat chronic hepatitis B virus infection.
Weekly visits for up to 48 weeks
Duration - 24 weeks
Participants are monitored for treatment effects and safety after the end of treatment.
Regular visits during 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
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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