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A Two-Part, Open-label, Single-Arm Phase Study of Safety, Pharmacokinetics, and Efficacy of Telaprevir in Combination With Peginterferon alfa-2b and Ribavirin in Pediatric Subjects Aged 3 to 17 infected with Genotype 1 Hepatitis C Virus
An open-label study of trial drug (Peg-IFN & RBV) for pediatric subjects infected with Hepatitis C virus
| Sponsor: | Vertex Pharmaceuticals Incorporated |
| Enrolling: | Male and Female Patients |
| Study Length: | 11 Months |
| IRB Number: | AAAK4703 |
| U.S. Govt. ID: | NCT01701063 |
| Contact: | Theresa Lukose: 212-305-3839 / tt2103@columbia.edu |
Additional Study Information:
The purpose of this study is to learn more about the effects of the combination of telaprevir peginterferon alfa2b (Peg-IFN) and ribavirin (RBV) in children with chronic hepatitis C. Investigators will look at how these study drugs may affect childrens bodies and how children break down and eliminate telaprevir. Participants of this study will receive Peg-IFN, ribavirin (RBV) for 24 weeks or 48 weeks and telaprevir for 12 weeks, along with RBV. During all parts of the study children will have testing done to check their health and the effects of the study drugs; these include tests such as, physical exams, ECGs and blood samples.
This study is closed
