Non-inferiority study of telaprevir dose reduction regimen on telaprevir with pegylated interferon and ribavirin therapy for treatment-experienced patients with chronic hepatitis C genotype 1; prospective randomized controlled, multicenter trial

Authors [No authors listed]
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2012
Links ICTRP
INTERVENTION: Telaprevir: 2250mg/day p.o., 12weeks Pegylated interferon alpha 2b: 1.5mcg/kg/week i.s., 24weeks Ribavirin: Body weight; less than 60kg, 600mg/day p.o., 24weeks, 60kg ‐ 80kg, 800mg/day p.o., 24 weeks, more than 80kg, 1000mg/day p.o., 24weeks Telaprevir: 1500mg/day p.o., 12weeks Pegylated interferon alpha 2b: 1.5mcg/kg/week i.s., 24weeks Ribavirin: Body weight; less than 60kg, 600mg/day p.o., 24weeks, 60kg ‐ 80kg, 800mg/day p.o., 24 weeks, more than 80kg, 1000mg/day p.o., 24weeks CONDITION: Chronic hepatitis C PRIMARY OUTCOME: ‐Sustained virological response rate; the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment SECONDARY OUTCOME: ‐Early virologic response; the rate of undetectable HCV RNA at 12 weeks of treatment; ‐End of treatment virologic response rate; the rate of undetectable HCV RNA at end of treatment ; ‐The rate of patients without treatment discontinuation due to adverse event ; ‐The rate of adverse events; ‐Drug adherence; ‐Transition of quality of life INCLUSION CRITERIA: 1) Patients over 20 years old 2) Patients with chronic infection with hepatitis C virus genotype 1 and more than 5 log IU/ml 3) Patients with previous history of pegylated interferon plus ribavirin therapy
Epistemonikos ID: 8dfa099eca84415550b4b564d015c4d1e9500c43
First added on: Aug 22, 2024