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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 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-07-20

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Vertex Pharmaceuticals Incorporated

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States
  • Belgium
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01701063 on ClinicalTrials.gov