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
Santa Clara, California 95051
711
mi
from 98109
Santa Clara, CA
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Albany, New York
2353
mi
from 98109
Albany, NY
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Albuquerque, New Mexico
1184
mi
from 98109
Albuquerque, NM
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Atlanta, Georgia
2178
mi
from 98109
Atlanta, GA
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Austin, Texas
1770
mi
from 98109
Austin, TX
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Boston, Massachusetts
2485
mi
from 98109
Boston, MA
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Celebration, Florida
2550
mi
from 98109
Celebration, FL
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Centralia, Illinois
1773
mi
from 98109
Centralia, IL
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Charleston, South Carolina
2423
mi
from 98109
Charleston, SC
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Charlotte, North Carolina
2281
mi
from 98109
Charlotte, NC
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Chevy Chase, Maryland 20815
2317
mi
from 98109
Chevy Chase, MD
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Denver, Colorado
1020
mi
from 98109
Denver, CO
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Lebanon, New Hampshire
2392
mi
from 98109
Lebanon, NH
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1931
mi
from 98109
Lima, OH
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Medford, Oregon
367
mi
from 98109
Medford, OR
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Metairie, Louisiana
2095
mi
from 98109
Metairie, LA
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Mountlake Terrace, Washington
10
mi
from 98109
Mountlake Terrace, WA
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Nashville, Tennessee
1971
mi
from 98109
Nashville, TN
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Newington, Connecticut
2429
mi
from 98109
Newington, CT
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Philadelphia, Pennsylvania
2373
mi
from 98109
Philadelphia, PA
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Providence, Rhode Island
2486
mi
from 98109
Providence, RI
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Richmond, Virginia
2351
mi
from 98109
Richmond, VA
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St Louis, Missouri
1720
mi
from 98109
St Louis, MO
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West Orange, New Jersey
2387
mi
from 98109
West Orange, NJ
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