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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vertex Pharmaceuticals Incorporated
With
Janssen Pharmaceuticals
Age
3–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | 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
