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
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Sponsor: Vertex Pharmaceuticals, Inc.
Location(s): United States
Description
The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with HCV on a telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.