Status:
COMPLETED
Virology Follow up Study in Subjects Previously Treated With Telaprevir
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborating Sponsors:
Tibotec Pharmaceutical Limited
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Brief Summary
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT00916474
Start Date
June 1 2009
End Date
December 1 2013
Last Update
February 27 2014
Active Locations (41)
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1
Alabama
Birmingham, Alabama, United States
2
California
Coronado, California, United States
3
California
Los Angeles, California, United States
4
California
San Francisco, California, United States