Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 719
Healthy volunteers: no

Brief summary:
The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.

Detailed description:

Arms:
arm 1: 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients arm 2: 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients arm 3: Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients arm 4: 120 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients arm 5: 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients arm 6: 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients arm 7: 240mg BI 201335 NA (Faldaprevir) twice daily combined with PegIFN/RBV for 24 or 48 weeks, with 3-day lead-in phase of PegIFN/RBV, in treatment-experienced patients

Interventions: intervention 1: BI 201335 NA 240 mg QD / LI intervention 2: PegIFN/RBV intervention 3: BI 201335 NA 120mg QD / LI intervention 4: PegIFN/RBV intervention 5: BI 201335 NA 240 mg QD intervention 6: PegIFN/RBV intervention 7: BI 201335 NA 240 mg QD intervention 8: PegIFN/RBV intervention 9: BI 201335 NA 240 mg BID intervention 10: PegIFN/RBV intervention 11: PegIFN/RBV intervention 12: BI 201335 NA 240 mg QD intervention 13: PegIFN/RBV intervention 14: Placebo
Intervention descriptions: intervention 1: 240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks intervention 2: PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks intervention 3: 120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks intervention 4: PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks intervention 5: 240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks intervention 6: PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks intervention 7: 240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks intervention 8: PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks intervention 9: 240mg BI 201335 NA (Faldaprevir) twice, 24 weeks intervention 10: PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks intervention 11: PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks intervention 12: 240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks intervention 13: PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks intervention 14: Placebo

Protocol document: