Virology Follow up Study in Subjects Previously Treated With Telaprevir

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00916474
First received: June 4, 2009
Last updated: February 26, 2014
Last verified: February 2014
  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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HCV variants with decreased sensitivity to telaprevir over time in subjects with late relapse [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916474

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

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00916474     History of Changes
Other Study ID Numbers: VX08-950-112
Study First Received: June 4, 2009
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014