Chronic hepatitis B
Conditions
Interventions
Nucleotide analogue daily, HBIG 1,000IU/month, HB vaccine 10-20ug/month
Sponsors
Department of Gastroenterology and Metabolism, Hiroshima university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic hepatitis B patients treated with nucleotide analogues. 2. The titers of HBs antigen was reduced less than 500 C.O.I. with the nucleotide analogue therapy. 3. Without liver cirrhosis and hepatocellular carcinoma.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug withdrawal rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMasataka Tsuge
Hiroshima university Department of Gastroenterology and Metabolism
Outcome results
None listed