Conditions: Hepatitis C
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 42
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.

Detailed description:

Arms:
arm 1: telaprevir + Peginterferon alfa-2b + Ribavirin

Interventions: intervention 1: Telaprevir intervention 2: Peginterferon alfa-2b intervention 3: Ribavirin
Intervention descriptions: intervention 1: 100- and 250-mg chewable tablets or 375-mg film-coated tablets for oral administration intervention 2: 50 μg/0.5 mL, 80 μg/0.5 mL, 120 μg/0.5 mL, or 150 μg/0.5 mL for subcutaneous (SC) injection intervention 3: 200-mg capsules or 40-mg/mL solution for oral administration

Protocol document: