An open-label single arm study to evaluate the safety and efficacy of 12-week simeprevir/peginterferon alpha-2a/ribavirin treatment in patients with chronic genotype 1 HCV infectio
Not Applicable
- Conditions
- chronic hepatitis C
- Registration Number
- JPRN-UMIN000012661
- Lead Sponsor
- Tokai University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Not provided
Exclusion Criteria
1. patients who received treatments containing telaprevir 2. pregnant women 3. patients allergic to ribavirin or IFN 4. patients with uncontrolled heart diseases 5. patients with abnormal hemoglobin 6. patients with chronic renal diseases 7. patients with severe depression or mental illness 8. patients with liver cirrhosis or liver failure 9. patients who cannot discontinue other antiviral or immunomodulating drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of patients with a sustained virologic response 12 weeks after planned end of treatment (SVR12)
- Secondary Outcome Measures
Name Time Method 1.The percentage of patients with a sustained virologic response 24 weeks after planned end of treatment (SVR24). 2.The percentage of patients whose serum HCV-RNA is undetectable at weeks 2, 4, 8, 12, 24, 36, and 48. 3.The percentage of relapsers. 4.The percentage of patients with breakthrough. 5.The percentage of patients who meet stopping criteria. 6.The percentage of patients who have adverse effects. 7.Relationship between IL-28B SNP and efficacy. 8.Relationship between HCV core 70 variants and efficacy. 9.Relationship between SNPs of SLCO1B1 and SLCO1B3, and simeprevir-induced hyperbilirubinemia. 10.Analysis of HCV variants resistant to simeprevir in breakthrough cases.