An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus

A Two-Part, Open-Label, Single-Arm Phase 1/2 Study of Safety, Pharmacokinetics, and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Aged 3 to 17 Infected With Genotype 1 Hepatitis C Virus

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.

Inclusion Criteria:

• Males or females ages 3 to 17 years of age
• Chronic hepatitis C
• Hepatitis C virus genotype 1a or b at the Screening Visit
• Subject is judged to be in good health (besides HCV infection) in the opinion of the investigator.
• Signed informed consent form (ICF), and where appropriate, signed Assent Form

Exclusion Criteria:

• History of or prior evidence of a medical condition associated with chronic liver disease other than HCV
• Body weight <15 kg or >90 kg
• Prior evidence of hepatic decompensation
• Contraindications to pegylated interferon/ribavirin (Peg-IFN/RBV)
• History or other evidence of severe retinopathy or clinically significant ophthalmological disorder
• History of non-genotype 1 HCV
• Participation in investigational drug study as described in Study Protocol
• Use of prohibited drugs within 7 days or 5 half-lives before the first dose of study drug