Virology Follow up Study in Subjects Previously Treated With Telaprevir

Completed

Conditions studied: Hepatitis C

In brief

Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.

Key facts

Study ID

NCT00916474

Run by

Vertex Pharmaceuticals Incorporated

People needed

408

Starts

2009-06-01

Expected to finish

2013-12-01

Last updated by the study team

2014-02-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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