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



Status:Recruiting
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:3 - 17
Updated:3/16/2015
Start Date:January 2013
End Date:August 2016
Contact:Central Contact Center
Email:medicalinfo@vrtx.com
Phone:617-341-6777

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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 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 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 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
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