Clinical study of combination therapy of HLBI plus SMP-275 ribavirin in patients with chronic hepatitis C
- Conditions
- Patients with following chronic hepatitis C (1)Patients with high blood HCV-RNA level (2)Patients who had no efficacy or had relapse after previous monotherapy of interferon preparation
- Registration Number
- JPRN-jRCT2080220092
- Lead Sponsor
- Dainippon Sumitomo Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
-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.
etc.
-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.
etc.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: The rate of undetectable HCV-RNA etc.
- Secondary Outcome Measures
Name Time Method