Virology Follow up Study in Subjects Previously Treated With Telaprevir
EXTEND: A 3-Year, Virology Follow up Study in Subjects Previously Treated With Telaprevir in Select Clinical Studies
1 other identifier
observational
408
5 countries
41
Brief Summary
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2009
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 4, 2009
CompletedFirst Posted
Study publicly available on registry
June 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFebruary 27, 2014
February 1, 2014
4.5 years
June 4, 2009
February 26, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment
3 years
Change in HCV variants with decreased sensitivity to telaprevir over time in subjects failing to achieve an SVR following telaprevir-based treatment
3 years
Secondary Outcomes (1)
Change in HCV variants with decreased sensitivity to telaprevir over time in subjects with late relapse
3 years
Study Arms (2)
Cohort A
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time
Cohort B
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time
Interventions
Eligibility Criteria
Subjects who have previously received at least 1 dose of telaprevir-based treatment (telaprevir plus peginterferon alfa 2a \[Peg IFN-alfa-2a\] with or without ribavirin \[RBV\]) in 1 of the following clinical studies: VX05-950-104, VX05 950-104EU, VX06-950-106, VX06-950-107, VX07-950-108, VX08-950-111, and VX-950-TiDP24-C216.
You may qualify if:
- Received at least 1 dose of telaprevir-based treatment in 1 of the following clinical studies: VX05-950-104, VX05-950-104EU, VX06-950-106, VX06-950-107, VX07-950-108, VX08-950-111, or VX-950-TiDP24-C216
- Have baseline HCV viral sequencing data available from previous telaprevir study
You may not qualify if:
- May not be currently participating in the antiviral follow-up period of an ongoing telaprevir trial. (Note: Subjects who have completed the required antiviral follow-up period but are still participating in the collection of patient-reported outcomes data for their previous telaprevir study may be eligible.)
- For subjects participating in ongoing studies at the time of enrollment, have more than 90 elapsed days between the database lock or unblinding in the previous telaprevir study and Day 1 in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Alabama
Birmingham, Alabama, United States
California
Coronado, California, United States
California
Los Angeles, California, United States
California
San Francisco, California, United States
Colorado
Denver, Colorado, United States
Colorado
Englewood, Colorado, United States
Florida
Gainsville, Florida, United States
Florida
Jacksonville, Florida, United States
Florida
Miami, Florida, United States
Georgia
Altanta, Georgia, United States
Maryland
Baltimore, Maryland, United States
Massachusetts
Boston, Massachusetts, United States
Michigan
Novi, Michigan, United States
Missouri
St Louis, Missouri, United States
New Mexico
Albuquerque, New Mexico, United States
New York
Manhasset, New York, United States
New York
New York, New York, United States
North Carolina
Chapel Hill, North Carolina, United States
North Carolina
Durham, North Carolina, United States
Ohio
Cincinnati, Ohio, United States
South Carolina
Columbia, South Carolina, United States
Texas
Houston, Texas, United States
Texas
San Antonio, Texas, United States
Virginia
Fairfax, Virginia, United States
Virginia
Falls Church, Virginia, United States
Canada
Vancouver, British Columbia, Canada
Canada
Toronto, Ontario, Canada
France
Clichy, France
France
Marseille, France
France
Paris, France
France
Pessac, France
France
Vandœuvre-lès-Nancy, France
Germany
Berlin, Germany
Germany
Cologne, Germany
Germany
Frankfurt, Germany
Germany
Freiburg im Breisgau, Germany
Germany
Hamburg, Germany
Germany
Hanover, Germany
Germany
Munich, Germany
Germany
Wien, Germany
Puerto Rico
Santurce, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Vertex Pharmaceuticals Incorporated
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2009
First Posted
June 9, 2009
Study Start
June 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
February 27, 2014
Record last verified: 2014-02