Chronic hepatitis C
Conditions
Interventions
Patients receive simeprevir and peginterferon alfa 2b/ribavirin for 12 weeks followed by peginterferon alfa 2b/ribavirin for 12 weeks
Patients receive simeprevir and peginterferon alfa 2a/ribavirin fo
Sponsors
Graduate School of Medical Sciences, Kumamoto University, Department of Gastroenterology and Hepatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.over than 20 years old 2.Positive of HCV-RNA and comfirmed the serogroup 1 HCV infection 3.Neutrophil count >1,500/microl, Platelet count > 80,000/microl and Hb > 10 g/dl 4.Absence of HCC 5.agreement of this trial and obtain informed consent 6.Not received PSE or splenectomy
Exclusion criteria
Exclusion criteria: 1.pregnancy or breast feeding female severe allergy to IFN 2, 3.severe allergy to RBV or nucreosid analogue 4.uncontrolled cardiac diseases 5.Hemoglobinopathies 6.chronic renal failure or less than 50 ml /min of CCr 7.severe psychiatric disorder 8.severe cirrhotic patients 9.The history of interstitial pneumonitis 10.Autoimmune hepatitis 11.The history of the allergy to biochemical agents 12.receiving disallowed drugs 13.uncontrolled diabetes mellitus 14.patients with HCC(except for curative patients) 15.co-infection of HBV and/or HIV 16.patients who not permit the participate this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of sustained virological response 24 weeks after the end of treatment | — |
Countries
Japan
Contacts
Public Contactmasakuni tateyama
Graduate School of Medical Sciences, Kumamoto University Department of Gastroenterology and Hepatology
Outcome results
None listed