Conditions: Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 160
Healthy volunteers: no

Brief summary:
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1

Detailed description:

Arms:
arm 1: patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV) arm 2: patients to receive BI201335 with PegIFN/RBV for 24 wks with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)

Interventions: intervention 1: BI 201335 intervention 2: BI 201335 intervention 3: Pegylated Interferon-alpha (IFN) intervention 4: Ribavirin (RBV)
Intervention descriptions: intervention 1: BI 201335 intervention 2: BI 201335 intervention 3: Pegylated Interferon-alpha intervention 4: Ribavirin (RBV)

Protocol document: