Virology Follow up Study in Subjects Previously Treated With Telaprevir

Completed

• Conditions: Hepatitis C
• Interventions: Drug: telaprevir

• Registration Number: NCT00916474
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-04
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	telaprevir	Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time
Cohort B	telaprevir	Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in HCV variants with decreased sensitivity to telaprevir over time in subjects with late relapse	3 years

Trial Locations

Locations (20)

Maryland; 🇺🇸 Baltimore, Maryland, United States

South Carolina; 🇺🇸 Columbia, South Carolina, United States

Florida; 🇺🇸 Miami, Florida, United States

Massachusetts; 🇺🇸 Boston, Massachusetts, United States

Ohio; 🇺🇸 Cincinnati, Ohio, United States

Texas; 🇺🇸 San Antonio, Texas, United States

New York; 🇺🇸 New York, New York, United States

Missouri; 🇺🇸 St. Louis, Missouri, United States

Virginia; 🇺🇸 Falls Church, Virginia, United States

Colorado; 🇺🇸 Englewood, Colorado, United States

Georgia; 🇺🇸 Altanta, Georgia, United States

Canada; 🇨🇦 Toronto, Ontario, Canada

New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

Puerto Rico; 🇵🇷 Santurce, Puerto Rico

France; 🇫🇷 Vandoeuvre les Nancy, France

Germany; 🇩🇪 Wien, Germany

Michigan; 🇺🇸 Novi, Michigan, United States

North Carolina; 🇺🇸 Durham, North Carolina, United States

Alabama; 🇺🇸 Birmingham, Alabama, United States

California; 🇺🇸 San Francisco, California, United States