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Trial record 1 of 1 for:    950-112
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Virology Follow up Study in Subjects Previously Treated With Telaprevir

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00916474
First Posted: June 9, 2009
Last Update Posted: February 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
  Purpose
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.

Condition Intervention
Hepatitis C Drug: telaprevir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EXTEND: A 3-Year, Virology Follow up Study in Subjects Previously Treated With Telaprevir in Select Clinical Studies

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment [ Time Frame: 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 ]

Secondary Outcome Measures:
  • Change in HCV variants with decreased sensitivity to telaprevir over time in subjects with late relapse [ Time Frame: 3 years ]

Enrollment: 408
Study Start Date: June 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916474


  Show 41 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Tibotec Pharmaceutical Limited
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00916474     History of Changes
Other Study ID Numbers: VX08-950-112
First Submitted: June 4, 2009
First Posted: June 9, 2009
Last Update Posted: February 27, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases