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Immunomodulatory Therapy and Predictors of Clinical Cure in Chronic Hepatitis B

RecruitingEARLY Phase 1Ages 18 Years - 60 YearsAllPeking University People's Hospital
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In plain words

What the trial is, and whether it could suit you

Achieving clinical cure, defined as hepatitis B surface antigen (HBsAg) seroclearance, represents a major research focus and an ideal therapeutic goal for chronic hepatitis B (CHB). A significant challenge in CHB management lies in promoting clinical cure, reducing relapse, and progressing towards complete cure. Studies have found that in patients who achieve HBsAg seroclearance following peginterferon alfa (PegIFNα) therapy, the seroconversion of anti-HBs and its attainment to a certain level are crucial for minimizing relapse. Strategies to promote anti-HBs seroconversion include active immunization (hepatitis B vaccine) and passive immunization (hepatitis B immunoglobulin, HBIG). Existing literature and preliminary findings from our team suggest that hepatitis B vaccine alone is ineffective in preventing relapse after clinical cure. This project proposes a multicenter, prospective, ra

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged 18 to 60 years (inclusive). 2. Documented HBsAg and/or HBV DNA positivity for over 6 months. 3. Achieved HBsAg seroclearance (\<0.05 IU/mL) following a PegIFNα-based treatment regimen. 4. HBeAg negative and HBV DNA \<10 IU/mL. 5. Good compliance and willingness to voluntarily sign the informed consent form. Exclusion Criteria: 1. Current decompensated cirrhosis or a history of decompensated cirrhosis. 2. Individuals with spontaneous or Nucleos(t)ide analogue-induced HBsAg seroclearance. 3. Coinfection with other viruses, such as hepatitis A, C, D, E viruses, or human immunodeficiency virus (HIV). 4. Severe concurrent physical or mental illnesses other than hepatitis B, including uncontrolled primary renal, cardiac, pulmonary, vascular, neurological, digestive, or severe metabolic diseases (e.g., uncontrolled hyperthyroidism, severe diabetic complications, adrenal disorders), immunodeficiency diseases, or severe infections; active or suspected malignancy, or a history of malignancy. 5. Use of corticosteroids, immunosuppressants, or chemotherapeutic agents within the 6 months prior to enrollment or at present. 6. Concurrent other liver diseases such as alcoholic liver disease or autoimmune liver disease. 7. Body Mass Index (BMI) \> 28 kg/m². 8. Any other condition considered by the investigator to potentially compromise patient compliance or otherwise make the patient unsuitable for participation in the study.
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What it tests

  • Hepatitis B Immunoglobulin (HBIg)
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Where

1 site
Peking University People's Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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