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

Vertex Pharmaceuticals

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Hepatitis C

Treatments

Drug: Telaprevir

Drug: Ribavirin

Drug: Peginterferon alfa-2b

Study type

Interventional

Funder types

Industry

Identifiers

NCT01701063

VX11-950-118

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

3 to 17 years old

Volunteers

No Healthy Volunteers

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