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
Status: | Recruiting |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 3 - 17 |
Updated: | 3/16/2015 |
Start Date: | January 2013 |
End Date: | August 2016 |
Contact: | Central Contact Center |
Email: | medicalinfo@vrtx.com |
Phone: | 617-341-6777 |
A Two-Part, Open-Label, Single-Arm Phase 1/2 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
The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a
carefully monitored cohort of pediatric subjects infected with HCV on a telaprevir-based
regimen in Part A and with dose adjustments if needed before Part B.
carefully monitored cohort of pediatric subjects infected with HCV on a telaprevir-based
regimen in Part A and with dose adjustments if needed before Part B.
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
- Subject is judged to be in good health (besides HCV infection) in the opinion of the
investigator.
- Signed ICF, and where appropriate, signed Assent Form
Exclusion Criteria:
- 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 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
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