NCT01701063

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Telaprevir	100- and 250-mg chewable tablets or 375-mg film-coated tablets for oral administration
DRUG	Peginterferon alfa-2b	50 μg/0.5 mL, 80 μg/0.5 mL, 120 μg/0.5 mL, or 150 μg/0.5 mL for subcutaneous (SC) injection
DRUG	Ribavirin	200-mg capsules or 40-mg/mL solution for oral administration

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2012-10-04
• Last updated: 2016-07-20
• Results posted: 2016-07-20

Locations

23 sites across 6 countries: United States, Belgium, Germany, Italy, Spain, United Kingdom