Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C
NCT ID: NCT00336479
Last Updated: 2014-07-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
263 participants
INTERVENTIONAL
2006-06-30
2008-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy
NCT00535847
A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)
NCT00420784
A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
NCT00627926
VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo
NCT01054573
A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
NCT01080222
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (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.
Ribavirin
tablet
Pegylated Interferon Alfa 2a
Solution for injection
Placebo
matching placebo tablet
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Single 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
tablet
Ribavirin
tablet
Pegylated Interferon Alfa 2a
Solution for injection
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
Single 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
tablet
Ribavirin
tablet
Pegylated Interferon Alfa 2a
Solution for injection
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Single 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.
Telaprevir
tablet
Ribavirin
tablet
Pegylated Interferon Alfa 2a
Solution for injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Telaprevir
tablet
Ribavirin
tablet
Pegylated Interferon Alfa 2a
Solution for injection
Placebo
matching placebo tablet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Call For Information
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University Liver Research
Palo Alto, California, United States
Call For Information
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, United States
Call for Information
Miami, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Clarian Hospital
Indianapolis, Indiana, United States
Gulf Coast Research Associates
Baton Rouge, Louisiana, United States
Call For Information
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Call for Information
Boston, Massachusetts, United States
Call For Information
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Call For Information
Rochester, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
Call For Information
Manhasset, New York, United States
Call for Information
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Call For Information
Chapel Hill, North Carolina, United States
Call For Information
Durham, North Carolina, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Fox Chase/ Temple Cancer Center
Philadelphia, Pennsylvania, 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, United States
Inova Fairfax Hospital
Annandale, Virginia, United States
University of Virginia Health System
Charlotteville, Virginia, United States
Metropolitan Research
Fairfax, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Fundacion de Investigacion de Diego
Santurce, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VX05-950-104
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.