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

Stopped early · Phase 1/Phase 2

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT01701063

Run by

Vertex Pharmaceuticals Incorporated

People needed

42

Starts

2013-01-01

Expected to finish

2015-04-01

Last updated by the study team

2016-07-20

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — San Francisco, California, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Brussels, Belgium
• Study site — Wuppertal, Germany
• Study site — Milan, Italy
• Study site — Padova, Italy
• Study site — Pisa, Italy
• Study site — Esplugues de Llobregat, Spain
• Study site — Madrid, Spain
• Study site — Birmingham, United Kingdom
• Study site — Leeds, United Kingdom
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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