VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection
NCT ID: NCT01241760
Last Updated: 2014-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
744 participants
INTERVENTIONAL
2010-12-31
2012-11-30
Brief Summary
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Detailed Description
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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 participant's treatment response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48, or at early discontinuation of all study drugs), participants with undetectable HCV RNA at end of treatment will be required to attend follow-up visits until Week 72 safety/tolerability assessments will be performed throughout the treatment period and during the follow-up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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001 T(q8h) / PR
Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
Ribavirin
Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
Pegylated interferon alfa-2a
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
Telaprevir
750 mg (2 oral tablets) every 8 hours for 12 weeks
002 T(b.i.d.) / PR
Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
Ribavirin
Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
Telaprevir
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
Pegylated interferon alfa-2a
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
Interventions
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Ribavirin
Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
Telaprevir
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
Pegylated interferon alfa-2a
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
Telaprevir
750 mg (2 oral tablets) every 8 hours for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Patients should not have had any previous treatment for hepatitis C
* Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
* Patients with cirrhosis should have serum alpha-fetoprotein (AFP) \<= 50 ng/mL. If AFP \> 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
* A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.
Exclusion Criteria
* Patient has a pre-existing psychiatric condition
* Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
* Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
* Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
18 Years
70 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Janssen Infectious Diseases BVBA
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Infectious Diseases BVBA Clinical Trial
Role: STUDY_DIRECTOR
Janssen Infectious Diseases BVBA
Locations
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La Jolla, California, United States
Los Angeles, California, United States
San Diego, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Bradenton, Florida, United States
Jacksonville, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Downers Grove, Illinois, United States
New Orleans, Louisiana, United States
Lutherville, Maryland, United States
Kansas City, Missouri, United States
Lebanon, New Hampshire, United States
Egg Harbor Twp, New Jersey, United States
Santa Fe, New Mexico, United States
New York, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Allentown, Pennsylvania, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Arlington, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Falls Church, Virginia, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Adelaide, , Australia
Camperdown, , Australia
Clayton, , Australia
Darlinghurst, , Australia
Fitzroy, , Australia
Greenslopes, , Australia
Melbourne, , Australia
Perth, , Australia
Graz, , Austria
Linz, , Austria
Vienna, , Austria
Antwerp, , Belgium
Brussels, , Belgium
Genk, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Liège, , Belgium
Campinas, , Brazil
Salvador, , Brazil
Santo André, , Brazil
São Paulo, , Brazil
Clichy, , France
Créteil, , France
Grenoble, , France
Lille, , France
Lyon, , France
Paris, , France
Pessac, , France
Vandœuvre-lès-Nancy, , France
Villejuif, , France
Berlin, , Germany
Bochum, , Germany
Essen, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Kiel, , Germany
Mainz, , Germany
Regensburg, , Germany
Dublin, , Ireland
Mex Ctity, , Mexico
México, , Mexico
Monterrey, , Mexico
Bialystok, , Poland
Bydgoszcz, , Poland
Czeladź, , Poland
Kielce, , Poland
Krakow, , Poland
Warsaw, , Poland
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Santander, , Spain
Seville, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Malmo, , Sweden
Stockholm, , Sweden
Birmingham, , United Kingdom
Edinburgh, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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Sarrazin C, Dierynck I, Cloherty G, Ghys A, Janssen K, Luo D, Witek J, Buti M, Picchio G, De Meyer S. An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay. J Clin Microbiol. 2015 Apr;53(4):1264-9. doi: 10.1128/JCM.03030-14. Epub 2015 Feb 4.
Buti M, Agarwal K, Horsmans Y, Sievert W, Janczewska E, Zeuzem S, Nyberg L, Brown RS Jr, Hezode C, Rizzetto M, Parana R, De Meyer S, De Masi R, Luo D, Bertelsen K, Witek J. Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C. Gastroenterology. 2014 Mar;146(3):744-753.e3. doi: 10.1053/j.gastro.2013.11.047. Epub 2013 Dec 4.
Other Identifiers
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OPTIMIZE-HCV
Identifier Type: OTHER
Identifier Source: secondary_id
VX-950-C211
Identifier Type: OTHER
Identifier Source: secondary_id
2010-021628-84
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR013711
Identifier Type: -
Identifier Source: org_study_id
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