The vaccine therapy for chronic hepatitis B

UMIN ID: UMIN000002568

Registered date:30/09/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic hepatitis B
• Date of first enrollment: 2009/09/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Nucleotide analogue daily, HBIG 1,000IU/month, HB vaccine 10-20ug/month

Outcome(s)

• Primary Outcome: Drug withdrawal rate
• Secondary Outcome: 1)Virological effects 2)Virological CR rate(Sustainment of negative status of HBV markers, such as HBs antigen, HBe antigen, HBV DNA, and positive status of anti-HBs antibody) 3)The conditions of the treatment 4)The relation between HBV drug resitants and virological responses 5)Serological responses 6)Quality of patients' life 7)Side effects of this study

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Department of Gastroenterology and Metabolism, Hiroshima university
• Source(s) of Monetary Support: Department of Gastroenterology and Metabolism, Hiroshima university