drugset
drugset / Trial / 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

NCT01701063 ↗

Phase 1/2 Terminated 42 enrolled Vertex Pharmaceuticals Incorporated Janssen Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-01
Primary completion
2015-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2b Protein / enzyme biologic 50 ug Subcutaneous
Subject Peginterferon alfa-2b Protein / enzyme biologic 80 ug Subcutaneous
Subject Peginterferon alfa-2b Protein / enzyme biologic 120 ug Subcutaneous
Subject Peginterferon alfa-2b Protein / enzyme biologic 150 ug Subcutaneous
Subject Ribavirin Small molecule 40 mg/ml Oral
Subject Ribavirin Small molecule 200 mg Oral
Subject Telaprevir Small molecule 100 mg Oral
Subject Telaprevir Small molecule 250 mg Oral
Subject Telaprevir Small molecule 375 mg Oral

Indications

hepatitis C virus infection