chronic hepatitis B
Conditions
Interventions
48 weeks of PEG-IFN alpha 2a treatment
Sponsors
Division of Gastroenterology, Department of Internal Medicine,Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with chronic hepatitis B treated with nucleoside analog, just before the trial, HBV DNA less than 2.1 log copies/mL for less than 1 years 2.Patient diagnosed as chronic hepatitis B before PEG-IFN alpha 2a medication, patients were eligible if they had . a neutrophil count of more than 1500/microliter . a platelet count of more than 90,000/microliter . a hemoglobin count of more than 10g/dl 3. The patient in which a liver biopsy is carried out before PEG-IFN alpha 2a medication in principle, and the result is not F4 4. Patients were not eligible if they had a HBs Ag count of more than 3.0 log copies /mL, and HBcrAg count of more than 4.0 log copies /mL in principle 5. Patients who understand fully the contents of the study and obtain agreement with documents for participation in present study by own free will
Exclusion criteria
Exclusion criteria: 1. The patient who has the resistant to nucleic acid analog, such as Lamivudine and Entecavir 2. Severe state of liver damage (the patient who conflicts with two items or more,total bilirubin is more than 2.0 mg/dl, prothrombin time is less than 70 %, and albumin is less than 3.6 g/dl) 3. Other chronic liver disease patients such as autoimmune hepatitis or alcoholic hepatitis 4. Severe state of complication, especially, patients were not eligible if they kept the function of bone marrow, kidney, heart, or respiration 5. Pregnant woman or woman who has possibility of pregnancy or woman while suckling 6. Patient who is administering the sho-sai-ko-to 7. A patient with the previous history of interstitial pneumonia 8. Patient who has previous history of hypersensitivity for element of PEG-IFN alpha 2a or other IFNs 9. Patient who has previous history of hypersensitivity for biological products such as vaccines 10. Patient who exists in serious state of mental disease of serious depression, thought of suicide or suicide plan, etc. or with these history 11. Additionally, patient judged by doctor that participation in this study is improper
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [HBeAg-positive chronic hepatitis B] This study had two predetermined primary measures of efficacy assessed after 24 weeks of follow up for 1) HBe seroconversion 2) the normalization of alanine aminotransferase levels (below 30IU/L) and the suppression of HBV DNA levels to below 5.0Log copies/ml [HBeAg-negative chronic hepatitis B] the normalization of alanine aminotransferase levels (below 30IU/L) and the suppression of HBV DNA levels to below 4.0Log copies/ml after 24 weeks of follow up | — |
Countries
Japan
Contacts
Public ContactYoshihiko Yano
Department of Internal Medicine, Kobe University Graduate School of Medicine Divison of Gastroenterology
Outcome results
None listed