Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 96
Healthy volunteers: no

Brief summary:
This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients.

A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.

Detailed description:

Arms:
arm 1: patient to receive 20mg solution BI201335 qd +/- PegIFN/RBV fore 28 days arm 2: patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV fore 28 days arm 3: patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV fore 28 days arm 4: patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV fore 28 days arm 5: None

Interventions: intervention 1: BI201335 intervention 2: BI201335 intervention 3: BI201335 intervention 4: BI201335 intervention 5: Placebo
Intervention descriptions: intervention 1: patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days intervention 2: patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days intervention 3: patient to receive rising doses of BI201335 solution qd +/- PegIFN/RBV fore 28 days intervention 4: patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV fore 28 days intervention 5: None

Protocol document: