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

Completed · Phase 2

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT00535847

Run by

Vertex Pharmaceuticals Incorporated

People needed

117

Starts

2007-10-01

Expected to finish

2010-02-01

Last updated by the study team

2014-08-05

Who can join

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

You may qualify if…

• Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)

Where it is running

• Study site — Los Angeles, California, United States
• Kaiser Permanente Internal Medicine — San Diego, California, United States
• Study site — 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
• Study site — Sarasota, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Study site — 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
• Study site — New York, New York, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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