Conditions: Hepatitis C, Chronic
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 107
Healthy volunteers: no

Brief summary:
The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C. The secondary objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in pediatric subjects with chronic hepatitis C.

Detailed description:
This global, multicenter, open-label Phase 3 study will evaluate the safety, efficacy and tolerability of PEG-Intron plus REBETOL in previously untreated pediatric subjects, ages 3 through 17 years, with chronic hepatitis C.

Arms:
arm 1: PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) and RBV 400-1200 mg/day by mouth divided in 2 daily doses (administered twice daily with food, dosed 12 hours apart) for 48 weeks. Subjects treated up to 48 weeks and followed for additional 24 weeks after the end of treatment (total of 72 weeks study participation).

Interventions: intervention 1: peginterferon alfa-2b (PEG2b) (SCH 54031) intervention 2: ribavirin (SCH 18908)
Intervention descriptions: intervention 1: PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) for 48 weeks. intervention 2: 15 mg/kg/day for up to 48 weeks

Protocol document: