A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
NCT ID: NCT00627926
Last Updated: 2014-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1095 participants
INTERVENTIONAL
2008-03-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to 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 48 weeks.
Pegylated Interferon Alfa 2a
subcutaneous injection, 180 micrograms once per week
Ribavirin
200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing ≥75 kg
Placebo
Telaprevir matching placebo
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 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 24 to 48 weeks depending on individual response to telaprevir treatment.
Pegylated Interferon Alfa 2a
subcutaneous injection, 180 micrograms once per week
Telaprevir
375 mg tablets administered orally every 8 hours at a dose of 750 mg
Ribavirin
200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing ≥75 kg
Placebo
Telaprevir matching placebo
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 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 24 to 48 weeks depending on individual response to telaprevir treatment.
Pegylated Interferon Alfa 2a
subcutaneous injection, 180 micrograms once per week
Telaprevir
375 mg tablets administered orally every 8 hours at a dose of 750 mg
Ribavirin
200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing ≥75 kg
Interventions
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Pegylated Interferon Alfa 2a
subcutaneous injection, 180 micrograms once per week
Telaprevir
375 mg tablets administered orally every 8 hours at a dose of 750 mg
Ribavirin
200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing ≥75 kg
Placebo
Telaprevir matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female subjects, 18 to 70 years of age, inclusive
* Genotype 1, chronic hepatitis C with detectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
* Screening laboratory values, tests, and physical exam within acceptable ranges
* Able and willing to follow contraception requirements
* Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions
Exclusion Criteria
* Evidence of hepatic decompensation in cirrhotic subjects
* History of organ transplant
* History of, or any current medical condition which could impact the safety of the subject in participation in the study
18 Years
70 Years
ALL
No
Sponsors
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Tibotec Pharmaceutical Limited
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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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Fresno, California, United States
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
San Francisco, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
South Miami, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Carmel, Indiana, United States
Indianapolis, Indiana, United States
Portland, Maine, United States
Baltimore, Maryland, United States
Laurel, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
Manhasset, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Valhalla, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Fayetteville, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Columbia, South Carolina, United States
Germantown, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Annandale, Virginia, United States
Charlottesville, Virginia, United States
Richmond, Virginia, United States
Buenos Aires, , Argentina
Darlinghurst, , Australia
Fitzroy, , Australia
Greenslopes, , Australia
Melbourne, , Australia
Perth, , Australia
Westmead, , Australia
Woolloongabba, , Australia
Linz, , Austria
Vienna, , Austria
Calgary, , Canada
Toronto, , Canada
Vancouver, , Canada
Winnipeg, , Canada
Clichy, , France
Créteil, , France
Grenoble, , France
Lyon, , France
Nice, , France
Paris, , France
Pessac, , France
Toulouse, , France
Berlin, , Germany
Bochum, , Germany
Cologne, , Germany
Düsseldorf, , Germany
Frankfurt, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
Hanover, , Germany
München, , Germany
Haifa, , Israel
Jerusalem, , Israel
Nazareth, , Israel
Petah Tikva, , Israel
Tel Litwinsky, , Israel
Bologna, , Italy
Milan, , Italy
Torino, , Italy
Bialystok, , Poland
Czeladź, , Poland
Kielce, , Poland
Krakow, , Poland
Lodz, , Poland
Wroclaw, , Poland
Santurce, , Puerto Rico
Barcelona, , Spain
Valencia, , Spain
Glasgow, , United Kingdom
Hampstead, , United Kingdom
London, , United Kingdom
Countries
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References
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Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912.
Other Identifiers
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VX07-950-108
Identifier Type: -
Identifier Source: org_study_id
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