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: Terminated
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Collaborator: Janssen Pharmaceuticals
• Treatments: Interferon-alpha; Peginterferon alfa-2b; Ribavirin

Criteria

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