The vaccine therapy for chronic hepatitis B

Phase 2

• Conditions: Chronic hepatitis B

• Registration Number: JPRN-UMIN000002568
• Lead Sponsor: Department of Gastroenterology and Metabolism, Hiroshima university

Brief Summary

Eight chronic hepatitis B patients, who had received long-term nucleotide analogue treatment, were treated with monthly HBIG injections as an additional treatment. After 1 year of treatment, an HBsAg level reduction of more than 1 log IU/mL was observed in four patients, and three patients became anti-HBs positive. No adverse events occurred during HBIG therapy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-30
• Study Completion: 2014-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

1. Hypersensitivity to nucleotide analogues, HBIG, HB vaccine or any other vaccines 2. Pregnant or nursing 3. Heart disease with uncontrolled status 4. Severe acute disease 5. Fever more than 37.5C 6. Renal dysfunction 7. IgA deficiency 8. Anemia caused by hemolysis or the loss of blood 9. Immunocompromised of immunosuppressive status 10. Chronic liver dysfunction except for HBV infection 11. The others who were disqualified to entry this trial by attending physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified