Conditions: Hepatitis C
Keywords: hepatitis C FNA intrahepatic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 15 subjects will receive Telaprevir in combination with pegylated interferon alfa-2a and ribavirin

Interventions: intervention 1: Telaprevir intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin
Intervention descriptions: intervention 1: 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). intervention 2: 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). intervention 3: 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).

Protocol document: