Virology Follow up Study in Subjects Previously Treated With Telaprevir

February 26, 2014 updated by: Vertex Pharmaceuticals Incorporated

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

408

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment
Time Frame: 3 years
3 years
Change in HCV variants with decreased sensitivity to telaprevir over time in subjects failing to achieve an SVR following telaprevir-based treatment
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in HCV variants with decreased sensitivity to telaprevir over time in subjects with late relapse
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Collaborators

Tibotec Pharmaceutical Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX08-950-112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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