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
A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response
1 other identifier
interventional
117
8 countries
62
Brief Summary
To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2007
62 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
September 25, 2007
CompletedFirst Posted
Study publicly available on registry
September 26, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
July 25, 2011
CompletedAugust 5, 2014
July 1, 2014
2.3 years
September 25, 2007
June 22, 2011
July 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment
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 treatment (up to Week 72)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
Baseline through Week 48
Secondary Outcomes (4)
Percentage of Prior Relapsers With Undetectable HCV RNA
24 weeks after the completion of treatment (up to Week 72)
Percentage of Subjects With End of Treatment Response
End of treatment (up to Week 48)
Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment
48 weeks after completion of treatment (up to Week 96)
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response
Baseline up to Week 72
Study Arms (3)
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
EXPERIMENTALTelaprevir 750 mg 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 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
EXPERIMENTALTelaprevir 750 mg 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.
Other
EXPERIMENTALSubjects received telaprevir 750 mg 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 \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.
Interventions
Tablet
Tablet
Solution for Injection
Eligibility Criteria
You may qualify if:
- Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vertex Pharmaceuticals Incorporatedlead
- Tibotec, Inccollaborator
Study Sites (62)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Los Angeles, California, United States
Kaiser Permanente Internal Medicine
San Diego, California, United States
Unknown Facility
San Francisco, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
South Denver Gastroenterology
Englewood, Colorado, United States
University of Florida
Gainesville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of Miami Center for Liver Diseases
Miami, Florida, United States
Unknown Facility
Sarasota, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Digestive and Liver Disease Clinic
Baton Rouge, Louisiana, United States
Virology Treatment Center, Maine Medical Center
Portland, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
St Louis University
St Louis, Missouri, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
University of New Mexico
Albuquerque, New Mexico, United States
North Shore University Hospital
Manhasset, New York, United States
Unknown Facility
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
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
Unknown Facility
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Unknown Facility
Annandale, Virginia, United States
University of Virginia Health Systems
Charlottesville, Virginia, United States
Metropolitan Research
Fairfax, Virginia, United States
McGuire DVAMC
Richmond, Virginia, United States
Unknown Facility
Vienna, Austria
University of Calgary Medical Clinic
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
University of British Columbia Vancouver General Hospital
Vancouver, British Columbia, Canada
Unknown Facility
Winnipeg, Manitoba, Canada
Unknown Facility
Toronto, Ontario, Canada
Hospital Henri Mondor
Créteil, France
Unknown Facility
Lyon, France
Unknown Facility
Nice, France
Unknown Facility
Paris, France
Unknown Facility
Pessac, France
Unknown Facility
Vandœuvre-lès-Nancy, France
Unknown Facility
Berlin, Germany
Universitatsklinikum Bonn
Bonn, Germany
University of Cologne
Cologne, Germany
Uniklinik Duesseldorf
Düsseldorf, 40225, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Hanover, Germany
Academic Medical Center
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Erasmus MC Medical Center
Rotterdam, Netherlands
Fundacion de Investigation de Diego
Santurce, Puerto Rico
Unknown Facility
London, United Kingdom
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
Nathalie Adda, MD
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2007
First Posted
September 26, 2007
Study Start
October 1, 2007
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
August 5, 2014
Results First Posted
July 25, 2011
Record last verified: 2014-07