Twenty-four-week anti-PD-1 antibody regimen promoted HBsAg reduction and concurrently enhanced HBV-specific T cell responses in patients with chronic hepatitis B.
Taiyu He, Min Chen, Maoying Liu...
https://pubmed.ncbi.nlm.nih.gov/41443982Actively Recruiting
Phase 2
Age: 18Years - 70Years
All Genders
ID05769816
A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (A)
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 poses a significant public health challenge, particularly in China. Current treatments with interferon or nucleos(t)ide analogues (NAs) achieve sustained Hepatitis B surface antigen (HBsAg) loss—a functional cure—in less than 10% of patients. This study aims to explore a novel combination therapy that includes an immune checkpoint inhibitor (anti-PD-1 antibody) alongside NAs to improve the rate of HBsAg loss, targeting over 50% functional cure in treated patients. The research builds on previous findings and intends to restore immune control by reversing T cell exhaustion caused by HBV infection. Participants will receive either a combination of NAs plus anti-PD-1 antibody or NAs alone. The anti-PD-1 antibody is administered subcutaneously or intravenously once every one to three weeks at a dose lower than that used for cancer treatment, while NAs are taken orally once daily. The study is a phase 2, non-randomized clinical trial conducted across multiple centers and expects to compare safety and efficacy outcomes between these groups to assess the potential of immune checkpoint blockade in achieving higher rates of clinical cure. Throughout the study, participants will have their serum HBsAg, HBV DNA, and alanine aminotransferase (ALT) levels measured at baseline, 24 weeks, 48 weeks after treatment, and 24 weeks post-treatment to monitor response and safety. The study involves regular assessments over a treatment period followed by a post-treatment observation period. Participants will be monitored closely for adverse effects and treatment adherence, contributing to a comprehensive evaluation of this combination strategy's impact on chronic HBV infection.
CONDITIONS
Brief Title
A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (A)
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Sign informed consent and able to complete study requirements
- Males or females of childbearing age willing to use effective contraception from inclusion until 30 days after last drug administration
- Aged 18 to 70 years
- Male weight at least 45 kg, female weight at least 40 kg
- Body mass index (BMI) between 18 and 32 kg/m²
- Chronic hepatitis B patients who are either nucleos(t)ide analogue naive or experienced
You will not qualify if you...
- History or suspicion of allergy to the study drug or its components
- Use of CYP3A4 inhibitors, inducers, or substrates within 28 days before enrollment
- Use of immunosuppressants, immunomodulators, or cytotoxic drugs within 6 months before enrollment, or live attenuated vaccine within 1 month before enrollment
- Acute infection requiring intravenous antibiotics within 2 weeks before enrollment or ongoing infection requiring treatment
- Significant acute or chronic liver diseases not caused by HBV
- Confirmed or suspected decompensated cirrhosis or progressive liver fibrosis
- Primary liver cancer, high alpha-fetoprotein levels, other malignancies within 5 years unless fully treated and stable
- History of pathological fracture or osteoporosis
- Gastrointestinal diseases affecting drug absorption or severe persistent symptoms
- Serious diseases affecting circulatory, respiratory, urinary, blood, metabolic, immune, mental, neurological, renal systems
- Major trauma or surgery within 3 months before enrollment or planned surgery during study
- Significant recent blood loss or transfusion
- Low blood cell counts or impaired liver/kidney function beyond specified limits
- Positive tests for hepatitis C, HIV, or syphilis
- History of continuous alcohol abuse exceeding 20 grams daily within 3 years
- History of drug dependence or abuse within 1 year
- Participation in other clinical trials with investigational drugs or devices within 3 months
- Pregnancy or breastfeeding
- Other factors judged by researchers as unsuitable for the study
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 48 weeks
Participants receive nucleos(t)ide analogues daily and may receive anti-PD-1 antibody injections once every two or three weeks depending on their group assignment.
Weekly or biweekly visits for drug administration and monitoring
Follow-up
Duration - 24 weeks after the end of treatment
Participants are monitored for safety and treatment outcomes after completing the treatment phase.
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
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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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