Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV)
The purpose of this study is to determine the decline of virus in the blood and liver in patients treated with telaprevir, pegylated interferon and ribavirin.
Fine Needle Aspiration (FNA) procedure will be used to repeatedly sample the liver to enhance the understanding of how the virus decays in the liver in response to treatment with anti-viral compounds and the measurement of the concentration of the drugs in the liver. FNA is an alternative procedure to core needle biopsy in its ability to repeatedly sample the liver with significantly reduced morbidity.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||#0810010040: Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus Infection: A Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects With Hepatitis C|
- Intrahepatic and plasma HCV viral kinetics in subjects treated with telaprevir, pegylated interferon and ribavirin [ Time Frame: Day-7, Day 1, Day 4, Day 15, Week 12, Week 16, Week 48 ] [ Designated as safety issue: No ]
- Intrahepatic and peripheral pharmacokinetic assessment of telaprevir [ Time Frame: Day-7, Day 1, Day 4, Day 15, Week 12, Week 16, Week 48 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.
Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy.