Conditions: Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 131
Healthy volunteers: no

Brief summary:
The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients

Detailed description:

Arms:
arm 1: low dose BI 201335 NA once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients arm 2: high dose BI 201335 NA once daily for 12 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients arm 3: high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients arm 4: high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 48 weeks in treatment-experienced (null responder, partial responder, breakthrough) patients

Interventions: intervention 1: BI 201335 high dose intervention 2: BI 201335 low dose intervention 3: BI 201335 high dose intervention 4: BI 201335 high dose
Intervention descriptions: intervention 1: BI 201335 high dose with PegIFN/RBV intervention 2: BI 201335 low dose with PegIFN/RBV intervention 3: BI 201335 high dose with PegIFN/RBV intervention 4: BI 201335 high dose with PegIFN/RBV

Protocol document: