Conditions: Hepatitis C
Keywords: Genotype 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1095
Healthy volunteers: no

Brief summary:
A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

Detailed description:

Arms:
arm 1: Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks. arm 2: Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment. arm 3: Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Interventions: intervention 1: Pegylated Interferon Alfa 2a intervention 2: Telaprevir intervention 3: Ribavirin intervention 4: Placebo
Intervention descriptions: intervention 1: subcutaneous injection, 180 micrograms once per week intervention 2: 375 mg tablets administered orally every 8 hours at a dose of 750 mg intervention 3: 200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing ≥75 kg intervention 4: Telaprevir matching placebo

Protocol document: