A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)
NCT ID: NCT00420784
Last Updated: 2014-08-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
465 participants
INTERVENTIONAL
2007-02-28
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir 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 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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
Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
Telaprevir
tablet
Pegylated Interferon Alfa 2a
Solution for injection
PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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.
Ribavirin
tablet
Pegylated Interferon Alfa 2a
Solution for injection
Matching Placebo
Tablet
Interventions
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Telaprevir
tablet
Ribavirin
tablet
Pegylated Interferon Alfa 2a
Solution for injection
Matching Placebo
Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or equal to (\>=) 10,000 international units per milliliter (IU/mL)
* Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
* Cannot also be infected with Human Immunodeficiency Virus or hepatitis B
* Must be judged to be in general good health and able to receive Pegasys® and Copegus®
* No drug or alcohol abuse in the last year
* Must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. One of the methods needs to be a 'barrier' method (condom or diaphragm)
* If you are a woman, you cannot be in this study if you are pregnant or nursing
Exclusion Criteria
* Prior response to therapy and failure to achieve SVR which was due to treatment non-compliance
* Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
* Diagnosed or suspected hepatocellular carcinoma
* History of or current evidence of decompensated liver disease
* Participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)
18 Years
70 Years
ALL
No
Sponsors
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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 Gastroenterology Associates
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
USC
Los Angeles, California, United States
Kaiser Permanente Hepatology Research
San Diego, California, United States
University of California, San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
Englewood, Colorado, United States
Bardenton, Florida, United States
University of Florida
Gainesville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Miami, Florida, United States
University Hepatitis Center at Bach & Godofsky
Sarasota, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, United States
Virology Treatment Center, Maine Medical Center
Portland, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Saint Louis University
St Louis, Missouri, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
North Shore University Hospital
Manhasset, New York, United States
New York, New York, United States
Durham, North Carolina, United States
University Internal Medicine Associates, Inc.
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Hershey, Pennsylvania, United States
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
Advanced Liver Therapies
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Annandale, Virginia, United States
Metropolitan Research
Fairfax, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
University of Calgary Medical Clinic - Health Science Centre
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
BC Hepatitis Program
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Universitatsmedizin Berlin
Berlin, , Germany
University Clinic Frankfurt, Department of Internal Medicine
Frankfurt, , Germany
Academic Medical Center
Amsterdam, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Erasmus MC University Medical Center
Rotterdam, , Netherlands
Santurce, , Puerto Rico
Countries
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References
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Li S, Zhu J, Zhang W, Chen Y, Zhang K, Popescu LM, Ma X, Lau WB, Rong R, Yu X, Wang B, Li Y, Xiao C, Zhang M, Wang S, Yu L, Chen AF, Yang X, Cai J. Signature microRNA expression profile of essential hypertension and its novel link to human cytomegalovirus infection. Circulation. 2011 Jul 12;124(2):175-84. doi: 10.1161/CIRCULATIONAHA.110.012237. Epub 2011 Jun 20.
McHutchison JG, Manns MP, Muir AJ, Terrault NA, Jacobson IM, Afdhal NH, Heathcote EJ, Zeuzem S, Reesink HW, Garg J, Bsharat M, George S, Kauffman RS, Adda N, Di Bisceglie AM; PROVE3 Study Team. Telaprevir for previously treated chronic HCV infection. N Engl J Med. 2010 Apr 8;362(14):1292-303. doi: 10.1056/NEJMoa0908014.
Other Identifiers
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VX06-950-106
Identifier Type: -
Identifier Source: org_study_id
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