chronic hepatitis B
Conditions
Interventions
PEG-IFN alpha-2a for the treatment of chronic hepatitis B
Sponsors
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient diagnosed as chronic hepatitis B 2.Before beginning therapy, 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 12g/dl . Patient who obtains agreement for participation in present study
Exclusion criteria
Exclusion criteria: 1.Patient who is administering the sho-sai-ko-to 2.A patient with the previous history of interstitial pneumonia 3.Other chronic liver disease patients such as autoimmune hepatitis or alcoholic hepatitis 4.Patient who has previous history of hypersensitivity for element of PEG-IFN alpha-2a or other IFNs 5.Patient who has previous history of hypersensitivity for biological products such as vaccines 6.Patient with cirrhosis, liver failure, and liver carcinoma 7.Hepatic encephalopathy, an esophageal varix, a patient with abdominal dropsy, or a patient with these previous history 8.A patient with autoimmune diseases (hemolytic anemia, chronic ulcerative colitis, rheumatoid arthritis, etc.), or a patient with these anamneses 9. Patient who has heart disease difficult to control (cardiac infarction, cardiac failure, and arrhythmia, etc.) 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. The patient of uncontrollable hypertension 12. A patient with the past of apoplexy (cerebral infarction, cerebral hemorrhage, subarachnoid bleeding, transient ischemic attack) 13. Pregnant woman or woman who has possibility of pregnancy or woman while suckling 14. Additionally, patient judged by doctor that participation in this study is improper
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [HBeAg-positive chronic hepatitis B] Efficacy assessed after 24 weeks of follow up for 1)HBeAg 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] Efficacy assessed after 24 weeks of follow up for 1)the suppression of HBV DNA levels to below 4.3Log copies/ml 2)the normalization of alanine aminotransferase levels (below 40IU/L) 3)the normalization of alanine aminotransferase levels (below 30IU/L), and the suppression of HBV DNA levels to below 4.0Log copies/ml | — |
Countries
Japan
Contacts
Public ContactYoshihiko Yano
Kobe University Hospital Gastroenterology
Outcome results
None listed