VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naive Patients With Genotype 1 Chronic Hepatitis C Virus Infection.



Status:Archived
Conditions:Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:February 2010
End Date:October 2012

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A Randomized, Open-label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-naive Subjects With Genotype 1 Chronic Hepatitis C Virus Infection.


The purpose of this study is to evaluate the effectiveness of telaprevir administered twice
daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in
treatment-naÃ-ve patients with chronic HCV genotype 1 infection.


This is a randomised (study drug assigned by chance), open-label (all persons know the study
drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered
orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with
Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin,
administered as an oral tablet twice a day, in treatment-naïve patients with chronic HCV
genotype 1 infection. Telaprevir will be given orally (by mouth) from Day 1 through Week 12
as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will
be administered once a week as an injection under the skin (180 microgram/week) from Day 1
through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is
administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the
patient's treatment response on week 4) as 1,000-1,200mg per day.


We found this trial at
24
sites
Charlotte, North Carolina
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Albany, New York
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Albuquerque, New Mexico
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Albuquerque, NM
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Atlanta, Georgia
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Atlanta, GA
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Austin, Texas
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Austin, TX
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Boston, Massachusetts
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Boston, MA
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Celebration, Florida
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Celebration, FL
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Centralia, Illinois
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Centralia, IL
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Charleston, South Carolina
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Charleston, SC
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Chevy Chase, Maryland 20815
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Chevy Chase, MD
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Denver, Colorado
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Denver, CO
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Lebanon, New Hampshire
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Lebanon, NH
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Lima, OH
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Medford, Oregon
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Medford, OR
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Metairie, Louisiana
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Metairie, LA
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Mountlake Terrace, Washington
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Mountlake Terrace, WA
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Nashville, Tennessee
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Nashville, TN
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Newington, Connecticut
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Newington, CT
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Philadelphia, Pennsylvania
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Philadelphia, PA
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Providence, Rhode Island
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Providence, RI
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Richmond, Virginia
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Richmond, VA
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Santa Clara, California 95051
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Santa Clara, CA
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St Louis, Missouri
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St Louis, MO
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West Orange, New Jersey
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West Orange, NJ
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