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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Page 1 of 11 (41 locations)

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