Clinical trial NCT00916474: Virology Follow up Study in Subjects Previously Treated With Telaprevir
Official title: EXTEND: A 3-Year, Virology Follow up Study in Subjects Previously Treated With Telaprevir in Select Clinical Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Tibotec Pharmaceutical Limited
First posted: 2009-06-09
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have previously received at least 1 dose of telaprevir-based treatment (telaprevir plus peginterferon alfa 2a \[Peg IFN-alfa-2a\] with or without ribavirin \[RBV\]) 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, and VX-950-TiDP24-C216.

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 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

Primary outcomes:
measure: Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment
timeFrame: 3 years
measure: Change in HCV variants with decreased sensitivity to telaprevir over time in subjects failing to achieve an SVR following telaprevir-based treatment
timeFrame: 3 years
Secondary outcomes:
measure: Change in HCV variants with decreased sensitivity to telaprevir over time in subjects with late relapse
timeFrame: 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama
state: Alabama
city: Coronado
country: United States
facility: California
state: California
city: Los Angeles
country: United States
facility: California
state: California
city: San Francisco
country: United States
facility: California
state: California
city: Denver
country: United States
facility: Colorado
state: Colorado
city: Englewood
country: United States
facility: Colorado
state: Colorado
city: Gainsville
country: United States
facility: Florida
state: Florida
city: Jacksonville
country: United States
facility: Florida
state: Florida
city: Miami
country: United States
facility: Florida
state: Florida
city: Altanta
country: United States
facility: Georgia
state: Georgia
city: Baltimore
country: United States
facility: Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts
state: Massachusetts
city: Novi
country: United States
facility: Michigan
state: Michigan
city: St. Louis
country: United States
facility: Missouri
state: Missouri
city: Albuquerque
country: United States
facility: New Mexico
state: New Mexico
city: Manhasset
country: United States
facility: New York
state: New York
city: New York
country: United States
facility: New York
state: New York
city: Chapel Hill
country: United States
facility: North Carolina
state: North Carolina
city: Durham
country: United States
facility: North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Ohio
state: Ohio
city: Columbia
country: United States
facility: South Carolina
state: South Carolina
city: Houston
country: United States
facility: Texas
state: Texas
city: San Antonio
country: United States
facility: Texas
state: Texas
city: Fairfax
country: United States
facility: Virginia
state: Virginia
city: Falls Church
country: United States
facility: Virginia
state: Virginia
city: Vancouver
country: Canada
facility: Canada
state: British Columbia
city: Toronto
country: Canada
facility: Canada
state: Ontario
city: Clichy
country: France
facility: France
city: Marseille
country: France
facility: France
city: Paris
country: France
facility: France
city: Pessac
country: France
facility: France
city: Vandoeuvre les Nancy
country: France
facility: France
city: Berlin
country: Germany
facility: Germany
city: Frankfurt
country: Germany
facility: Germany
city: Freiburg
country: Germany
facility: Germany
city: Hamburg
country: Germany
facility: Germany
city: Hannover
country: Germany
facility: Germany
city: Koln
country: Germany
facility: Germany
city: Munich
country: Germany
facility: Germany
city: Wien
country: Germany
facility: Germany
city: Santurce
country: Puerto Rico
facility: Puerto Rico
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References: