Actively Recruiting
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
168 weeks
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
Hepatitis B virus (HBV) infection is a major public health threat in China. At present, a functional cure, also known as clinical cure or sustained Hepatitis B surface antigen (HBsAg) loss, is recommended as the ideal endpoint of HBV treatment. However, HBsAg loss can be achieved in less than 10% of chronic hepatitis B (CHB) patients treated with current available antiviral drug interferon (IFNα) or nucleos(t)ide analogues (NAs) monotherapy. With the support of the national major special funding for infectious diseases from "11th Five-Year Plan" to "13th Five-Year Plan", we have implemented a pioneer clinical study of sequential combination of IFNα therapy on NAs to treat NAs-treated CHB patients (ie. New Switch Study). This is the world's first clinical trial aiming to functional cure, which increased the rate of HBsAg loss to 15% in the overall population in our study, and to 30-50% among those with lower baseline HBsAg levels. How to further improve the HBsAg loss rate is an urgent issue for us. The key point of achieving functional cure is to reverse the HBV-specific T cell exhaustion and establish the long-term immune control against HBV infection. Programmed death-1 (PD-1)/ programmed death-ligand 1 (PD-L1) axis blockade has been demonstrated to reinvigorate exhausted CD8+ T cells, and would be a potential strategy to treat chronic HBV infection. In this study, a large multicenter prospective study will be performed to explore the safety and efficacy of a novel combination strategy involving immune checkpoint inhibitor (anti-PD-1 antibody) in CHB patients, observe the HBsAg loss rate in NA-treated CHB patients receiving this combination strategy, evaluate the potential of breaking immune tolerance by this strategy, and further assess its efficacy to further improve the clinical cure rate on the basis of New Switch Study. Based on New Switch Study, this study further attempts to reverse T cell exhaustion in CHB patients, explore a novel platform of combination therapy development for clinical cure, and ultimately increase the HBsAg loss rate to higher than 50% in overall patients. The implementation of the project is expected to reduce the burden of HBV infection in China and contribute to the goal of global elimination of hepatitis B and C by 2030 (WHO 2030).
CONDITIONS
Official Title
A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (A)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sign the informed consent form and be able to complete the study as required
- Agree to use effective contraception from inclusion until 30 days after last study drug dose if male or female of childbearing age
- Be 18 to 70 years old
- Male participants must weigh at least 45 kg; female participants must weigh at least 40 kg
- Have a body mass index (BMI) between 18 and 32 kg/m2
- Have chronic hepatitis B and be either nucleos(t)ide analogue (NAs) 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 (like thymosin), cytotoxic drugs within 6 months before enrollment
- Vaccination with live attenuated vaccine within 1 month before enrollment
- Acute infection requiring intravenous antibiotics within 2 weeks before enrollment or ongoing infection needing treatment at enrollment
- Significant acute or chronic liver diseases not caused by hepatitis B
- Confirmed or suspected decompensated cirrhosis or progressive liver fibrosis
- Primary liver cancer, elevated AFP (>50 ug/L), suspected malignant liver lesions, other cancers or history of cancer within 5 years (except fully treated and stable for 3 years)
- History of pathological fracture or osteoporosis
- Gastrointestinal disorders affecting oral drug absorption
- Serious diseases affecting circulatory, respiratory, urinary, blood, metabolic, immune, mental, neurological, or renal systems
- Major trauma or surgery within 3 months before enrollment or planned surgery during the study
- Significant blood loss or transfusion within 3 months before enrollment
- Low platelet, white blood cell, or neutrophil counts; high bilirubin; low albumin; reduced kidney function; or high INR unless on stable anticoagulants
- Positive for hepatitis C, HIV, or syphilis infections
- History of continuous alcohol abuse within 3 years before enrollment
- History of drug dependence or abuse within 1 year before enrollment
- Participation in other clinical trials with investigational drugs or devices within 3 months before enrollment
- Pregnant or breastfeeding females
- Other factors deemed unsuitable by the researcher
AI-Screening
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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
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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