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
Recruiting in Palo Alto (17 mi)
+23 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Vertex Pharmaceuticals Incorporated
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Eligibility 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
See 2 more
Treatment Details
Interventions
- Peginterferon alfa-2b (Interferon)
- Ribavirin (Nucleoside Analog)
- Telaprevir (Protease Inhibitor)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment-Naive or Prior Partial/Null ResponseExperimental Treatment3 Interventions
telaprevir + Peginterferon alfa-2b + Ribavirin
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT01701063New York, NY
NCT01701063Baltimore, MD
NCT01701063Bronx, NY
NCT01701063Houston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Vertex Pharmaceuticals IncorporatedLead Sponsor
Janssen PharmaceuticalsIndustry Sponsor