Telaprevir therapy in Japanese patients infected with HCV
Not Applicable
- Conditions
- Chronic hepatitis C patients
- Registration Number
- JPRN-UMIN000007912
- Lead Sponsor
- Chiba University, Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1) Hemoglobin <12g/dl, Neutrophil < 1500/mm3, or Platelet count <100000/mm3 2) Drug allergy to telaprevir, interferon, ribavirin or nucleoside analogues 3) Past-history of dermatological reaction of teraprevir 4) Pregnant women, etc. 5) Women cannot prevent conception. 6) Men cannot prevent conception. 7) Severe heart diseases 8) Abnormal hemoglobinemia 9) Severe renal dysfunction 10) Uncontrolable mental illness 11) Severe liver diseases 12) Uncontrolable autoimmune diseases 13) Past-history of hypersensitivity against vaccination, etc. 14) Patients take prohibited drugs, which interacts with telaprevir. 15) Doctors judged patients as inappropriate persons in this trial
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anti-viral effects against HCV
- Secondary Outcome Measures
Name Time Method 1) Association between IL28SNP and treatment response 2) Treatment response and HCV RNA dynamics 3) HCV genome and treatment response