Virology Follow up Study in Subjects Previously Treated With Telaprevir

Hepatitis C Clinical Trial

Official title:

EXTEND: A 3-Year, Virology Follow up Study in Subjects Previously Treated With Telaprevir in Select Clinical Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916474
• Other study ID #: VX08-950-112
• Status: Completed
• Phase: N/A
• First received: June 4, 2009
• Last updated: February 26, 2014
• Start date: June 2009
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• telaprevir

Locations

Country	Name	City	State
Canada	Canada	Toronto	Ontario
Canada	Canada	Vancouver	British Columbia
France	France	Clichy
France	France	Marseille
France	France	Paris
France	France	Pessac
France	France	Vandoeuvre les Nancy
Germany	Germany	Berlin
Germany	Germany	Frankfurt
Germany	Germany	Freiburg
Germany	Germany	Hamburg
Germany	Germany	Hannover
Germany	Germany	Koln
Germany	Germany	Munich
Germany	Germany	Wien
Puerto Rico	Puerto Rico	Santurce
United States	New Mexico	Albuquerque	New Mexico
United States	Georgia	Altanta	Georgia
United States	Maryland	Baltimore	Maryland
United States	Alabama	Birmingham	Alabama
United States	Massachusetts	Boston	Massachusetts
United States	North Carolina	Chapel Hill	North Carolina
United States	Ohio	Cincinnati	Ohio
United States	South Carolina	Columbia	South Carolina
United States	California	Coronado	California
United States	Colorado	Denver	Colorado
United States	North Carolina	Durham	North Carolina
United States	Colorado	Englewood	Colorado
United States	Virginia	Fairfax	Virginia
United States	Virginia	Falls Church	Virginia
United States	Florida	Gainsville	Florida
United States	Texas	Houston	Texas
United States	Florida	Jacksonville	Florida
United States	California	Los Angeles	California
United States	New York	Manhasset	New York
United States	Florida	Miami	Florida
United States	New York	New York	New York
United States	Michigan	Novi	Michigan
United States	Texas	San Antonio	Texas
United States	California	San Francisco	California
United States	Missouri	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated	Tibotec Pharmaceutical Limited

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment		3 years	No
Primary	Change in HCV variants with decreased sensitivity to telaprevir over time in subjects failing to achieve an SVR following telaprevir-based treatment		3 years	No
Secondary	Change in HCV variants with decreased sensitivity to telaprevir over time in subjects with late relapse		3 years	No