Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C
A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Received Prior Treatment
1 other identifier
interventional
263
2 countries
37
Brief Summary
Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2006
37 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
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 9, 2006
CompletedFirst Posted
Study publicly available on registry
June 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
July 21, 2011
CompletedJuly 23, 2014
June 1, 2014
1.7 years
June 9, 2006
June 22, 2011
June 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
24 weeks after the completion of study drug dosing (up to Week 72)
Secondary Outcomes (4)
Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing
12 weeks after the completion of study drug dosing (up to Week 60)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to Week 48
Number of Subjects With Viral Relapse
After last dose of study drug up to antiviral follow-up (up to Week 72)
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85
Study Arms (4)
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
PLACEBO COMPARATORPlacebo (PBO) matched to telaprevir tablet orally 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.
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
EXPERIMENTALSingle loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
EXPERIMENTALSingle loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 weeks.
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
EXPERIMENTALSingle loading dose of telaprevir 1250 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 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 12 weeks.
Interventions
tablet
tablet
Solution for injection
Eligibility Criteria
You may qualify if:
- Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
- Have been infected with hepatitis C virus for greater than (\>) 6 months
- Seronegative for hepatitis B surface antigen and Human Immunodeficiency Virus 1 and 2
- Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
- Female subjects must have a negative pregnancy test at all visits before the first dose
You may not qualify if:
- Received any approved or investigational drug or drug regimen for the treatment of hepatitis C
- Any medical contraindications to Pegylated Interferon Alfa 2a or Ribavirin therapy
- 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
- Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start
- Alcohol abuse or excessive use in the last 12 months
- Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
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Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University Liver Research
Palo Alto, California, United States
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San Francisco, California, United States
University of Colorado Hospital
Denver, Colorado, United States
South Denver Gastroenterology
Englewood, Colorado, United States
Shands Hospital University of Florida
Gainesville, Florida, 32610, United States
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Miami, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Clarian Hospital
Indianapolis, Indiana, 46202, United States
Gulf Coast Research Associates
Baton Rouge, Louisiana, United States
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Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
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Rochester, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
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Manhasset, New York, United States
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New York, New York, United States
Columbia University Medical Center
New York, New York, United States
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Fox Chase/ Temple Cancer Center
Philadelphia, Pennsylvania, 19140, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
Methodist Hospital of Dallas
Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Inova Fairfax Hospital
Annandale, Virginia, 22003, United States
University of Virginia Health System
Charlotteville, Virginia, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Fundacion de Investigacion de Diego
Santurce, 00909, Puerto Rico
Related Publications (1)
McHutchison JG, Everson GT, Gordon SC, Jacobson IM, Sulkowski M, Kauffman R, McNair L, Alam J, Muir AJ; PROVE1 Study Team. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med. 2009 Apr 30;360(18):1827-38. doi: 10.1056/NEJMoa0806104.
PMID: 19403902DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeff Chodakewitz, M.D.
- Organization
- Vertex Pharmaceuticals Incorporated
Study Officials
- STUDY DIRECTOR
Medical Monitor
Vertex Pharmaceuticals Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2006
First Posted
June 13, 2006
Study Start
June 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
July 23, 2014
Results First Posted
July 21, 2011
Record last verified: 2014-06