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
NCT ID: NCT01701063
Last Updated: 2016-07-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
42 participants
INTERVENTIONAL
2013-01-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment-Naive or Prior Partial/Null Response
telaprevir + Peginterferon alfa-2b + Ribavirin
Telaprevir
100- and 250-mg chewable tablets or 375-mg film-coated tablets for oral administration
Peginterferon alfa-2b
50 μg/0.5 mL, 80 μg/0.5 mL, 120 μg/0.5 mL, or 150 μg/0.5 mL for subcutaneous (SC) injection
Ribavirin
200-mg capsules or 40-mg/mL solution for oral administration
Interventions
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Telaprevir
100- and 250-mg chewable tablets or 375-mg film-coated tablets for oral administration
Peginterferon alfa-2b
50 μg/0.5 mL, 80 μg/0.5 mL, 120 μg/0.5 mL, or 150 μg/0.5 mL for subcutaneous (SC) injection
Ribavirin
200-mg capsules or 40-mg/mL solution for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
3 Years
17 Years
ALL
No
Sponsors
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Janssen Pharmaceuticals
INDUSTRY
Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
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Phoenix, Arizona, United States
San Francisco, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Miami, Florida, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
New York, New York, United States
The Bronx, New York, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Seattle, Washington, United States
Brussels, , Belgium
Wuppertal, , Germany
Milan, , Italy
Padua, , Italy
Pisa, , Italy
Esplugues de Llobregat, , Spain
Madrid, , Spain
Birmingham, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Countries
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Other Identifiers
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VX11-950-118
Identifier Type: -
Identifier Source: org_study_id
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