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
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-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
4 other identifiers
interventional
744
12 countries
91
Brief Summary
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-naïve participants with chronic HCV genotype 1 infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2010
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2010
CompletedFirst Posted
Study publicly available on registry
November 16, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
June 4, 2014
CompletedJune 4, 2014
May 1, 2014
1.7 years
October 28, 2010
September 23, 2013
May 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)
The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
End of trial, 12 weeks after last planned dose
Secondary Outcomes (6)
Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)
End of trial, 24 weeks after last planned dose
Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)
End of trial, 72 weeks after the start of study medication
Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.
Baseline, Week 4 and Week 4+12.
Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs
Week 4, 12, 24, 32, 40
Percentage of Participants Who Relapsed During Follow-up Period
During Follow-Up (24 weeks after the last dose of study drug)
- +1 more secondary outcomes
Study Arms (2)
001 T(q8h) / PR
EXPERIMENTALTelaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
002 T(b.i.d.) / PR
EXPERIMENTALTelaprevir (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)
Interventions
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
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
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
Eligibility Criteria
You may qualify if:
- Patient has chronic HCV infection genotype 1 with HCV RNA level \> 1,000 IU/mL
- 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.
You may not qualify if:
- Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (99)
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La Jolla, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Bradenton, Florida, United States
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Jacksonville, Florida, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Downers Grove, Illinois, United States
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New Orleans, Louisiana, United States
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Lutherville, Maryland, United States
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Kansas City, Missouri, United States
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Lebanon, New Hampshire, United States
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Egg Harbor Twp, New Jersey, United States
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Santa Fe, New Mexico, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Statesville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Allentown, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Falls Church, Virginia, United States
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Norfolk, Virginia, United States
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Seattle, Washington, United States
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Adelaide, Australia
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Camperdown, Australia
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Clayton, Australia
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Darlinghurst, Australia
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Fitzroy, Australia
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Greenslopes, Australia
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Melbourne, Australia
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Perth, Australia
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Graz, Austria
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Linz, Austria
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Vienna, Austria
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Antwerp, Belgium
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Brussels, Belgium
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Genk, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Campinas, Brazil
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Salvador, Brazil
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Santo André, Brazil
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São Paulo, Brazil
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Clichy, France
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Créteil, France
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Grenoble, France
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Lille, France
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Lyon, France
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Paris, France
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Pessac, France
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Vandœuvre-lès-Nancy, France
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Villejuif, France
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Berlin, Germany
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Bochum, Germany
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Essen, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Kiel, Germany
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Mainz, Germany
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Regensburg, Germany
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Dublin, Ireland
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Mex Ctity, Mexico
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México, Mexico
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Monterrey, Mexico
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Bialystok, Poland
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Bydgoszcz, Poland
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Czeladź, Poland
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Kielce, Poland
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Krakow, Poland
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Warsaw, Poland
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Barcelona, Spain
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Madrid, Spain
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Málaga, Spain
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Santander, Spain
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Seville, Spain
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Valencia, Spain
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Gothenburg, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Birmingham, United Kingdom
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Edinburgh, United Kingdom
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Glasgow, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
Related Publications (2)
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.
PMID: 25653396DERIVEDButi 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.
PMID: 24316262DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Compound Development Team Leader
- Organization
- Janssen Infectious Diseases BVBA
Study Officials
- STUDY DIRECTOR
Janssen Infectious Diseases BVBA Clinical Trial
Janssen Infectious Diseases BVBA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2010
First Posted
November 16, 2010
Study Start
December 1, 2010
Primary Completion
August 1, 2012
Study Completion
November 1, 2012
Last Updated
June 4, 2014
Results First Posted
June 4, 2014
Record last verified: 2014-05