A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy
NCT ID: NCT00535847
Last Updated: 2014-08-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
117 participants
INTERVENTIONAL
2007-10-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.
Telaprevir
Tablet
Ribavirin
Tablet
Pegylated interferon alfa 2a
Solution for Injection
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
Telaprevir
Tablet
Ribavirin
Tablet
Pegylated interferon alfa 2a
Solution for Injection
Other
Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.
Telaprevir
Tablet
Ribavirin
Tablet
Pegylated interferon alfa 2a
Solution for Injection
Interventions
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Telaprevir
Tablet
Ribavirin
Tablet
Pegylated interferon alfa 2a
Solution for Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Tibotec, Inc
INDUSTRY
Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Nathalie Adda, MD
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
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Birmingham, Alabama, United States
Los Angeles, California, United States
Kaiser Permanente Internal Medicine
San Diego, California, United States
San Francisco, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
South Denver Gastroenterology
Englewood, Colorado, United States
University of Florida
Gainesville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of Miami Center for Liver Diseases
Miami, Florida, United States
Sarasota, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Digestive and Liver Disease Clinic
Baton Rouge, Louisiana, United States
Virology Treatment Center, Maine Medical Center
Portland, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
St Louis University
St Louis, Missouri, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
University of New Mexico
Albuquerque, New Mexico, United States
North Shore University Hospital
Manhasset, New York, United States
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Columbia Gastroenterology Associates, PA
Columbia, South Carolina, United States
Memphis Gastroenterology Group
Germantown, Tennessee, United States
Liver Institute at Methodist Dallas
Dallas, Texas, United States
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Annandale, Virginia, United States
University of Virginia Health Systems
Charlottesville, Virginia, United States
Metropolitan Research
Fairfax, Virginia, United States
McGuire DVAMC
Richmond, Virginia, United States
Vienna, , Austria
University of Calgary Medical Clinic
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
University of British Columbia Vancouver General Hospital
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Toronto, Ontario, Canada
Hospital Henri Mondor
Créteil, , France
Lyon, , France
Nice, , France
Paris, , France
Pessac, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
University of Cologne
Cologne, , Germany
Uniklinik Duesseldorf
Düsseldorf, , Germany
Frankfurt, , Germany
Hanover, , Germany
Academic Medical Center
Amsterdam, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Erasmus MC Medical Center
Rotterdam, , Netherlands
Fundacion de Investigation de Diego
Santurce, , Puerto Rico
London, , United Kingdom
Countries
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Other Identifiers
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VX06-950-107
Identifier Type: -
Identifier Source: org_study_id
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