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

Study on Novel Immunomodulatory Therapeutic Regimens for Clinical Cure of Chronic Hepatitis B and Efficacy Prediction

This trial will test whether giving hepatitis B immunoglobulin to adults who cleared HBsAg after peginterferon helps them develop protective anti‑HBs antibodies and lowers the chance of relapse.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07328711 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–60 who achieved HBsAg seroclearance after a peginterferon alfa regimen, are HBeAg-negative with HBV DNA <10 IU/mL, and can comply with follow-up visits are the ideal candidates.

Not a fit: Those with current or prior decompensated cirrhosis, coinfections (e.g., HCV, HDV, HIV), spontaneous or nucleos(t)ide analogue-induced seroclearance, or severe uncontrolled comorbidities are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, HBIG could raise protective anti‑HBs antibody levels and reduce the risk of hepatitis B returning after HBsAg clearance.

How similar studies have performed: Small observational reports and preliminary data suggest passive immunization can increase anti‑HBs, but randomized evidence is limited and this approach remains relatively unproven at scale.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Bo Feng

Conditions Chronic Hepaititis B; hepatitis B immunoglobulin; functional cure