Clinical study of combination therapy of HLBI plus SMP-275 ribavirin in patients with chronic hepatitis C

Dainippon Sumitomo Pharma Co., Ltd.0 个研究点开始时间: 2005年9月12日最近更新: 2023年10月17日

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•-Patients aged 20 or older
•-A willingness by all patients (without distinctive of sex) to utilized adequate contraception
•-Patients with hepatitis C which HCV sero-group or genotype has been identified, and who are classified in following criteria by quantitative HCV-RNA analysis within 90 days prior to administration in this study.
•(1)Patients with high blood HCV-RNA level and its genotype 1b.
•(2)Patients with high blood HCV-RNA level and its genotype non-1b. Or patients who are blood HCV-RNA positive, and have no efficacy or had relapse after previous mono therapy of interferon.
•-Patients, who are diagnosed as chronic hepatitis based on the criteria defined by the study protocol.
•-Patients who are able to admit to the hospital for 2 weeks or more.
•-Patients with HBs antigen positive within 180 days prior to administration in this study.
•-Patients with autoimmune disease or patients who are suspected of having autoimmune disease.
•-Patients with hepatic cirrhosis, hepatic carcinoma and hepatic failure, or patients with a history of this disease.
•-Patients with autoimmune hepatitis.
•-Patients with chronic hepatitis except C type viral hepatitis, such as alcoholic hepatitis.
•-Patients with serious depression or serious psychiatric disorder or patients with a history of these disorders.
•-Patients with desire to commit suicide and suicide attempt, or patients with a history of these disorders.
•-Patients with both hypertension and diabetes mellitus.

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