Chronic hepatitis C
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients over 20 years of age 2) Pre-treatment hemoglobin level is below 13 g/dl 3) HCV patients with serogroup 1 and high viral load 4) Patients with IL28B and ITPA genotypes determined
Exclusion criteria
Exclusion criteria: 1) Patients over 70 years of age 2) Patients with liver cirrhosis 3) Patients with hepatocellular carcinoma or other malignancies 4) Patients co-infected with HIV or HBV 5) Patients judged by doctor that participation in the study is improper
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence of telaprevir/PEG-IFN/RBV triple combination therapy up to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change of hemoglobin level 2) Differences of treatment efficacy depending on IL28B or ITPA genotypes 3) Correlation between drug adherence of telaprevir/PEG-IFN/RBV and treatment efficacy 4) Ratio of discontinuation and treatment duration of telaprevir/PEG-IFN/RBV 5) Correlation between viral mutation and treatment efficacy 6) Correlation between drug adherence and telaprevir-resistant viral mutation 7) Correlation between telaprevir-resistant viral mutation and plasma concentration of telaprevir 8) Difference of treatment efficacy depending on administration of erythropoietin | — |
Countries
Japan
Contacts
Nagoya City University, Graduate School of Medical Sciences Department of Gastroenterology and Metabolism