Using hepatitis B immunoglobulin to boost lasting cure after peginterferon in chronic hepatitis B

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase interventional randomized trial enrolls adults with chronic hepatitis B who achieved HBsAg seroclearance following peginterferon alfa therapy and are HBeAg-negative with very low HBV DNA. Participants will be randomized to receive hepatitis B immunoglobulin (HBIG) or control and followed prospectively for anti‑HBs seroconversion, antibody levels, HBV DNA, and clinical relapse. The protocol emphasizes safety monitoring along with preliminary efficacy signals appropriate for an early‑phase trial. Outcomes will inform whether passive immunization can help sustain functional cure after HBsAg loss.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Bo Feng
• Email: fengbo@pkuph.edu.cn
• Phone: 8613810254109

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.