Virology Follow up Study in Subjects Previously Treated With Telaprevir

NCT ID: NCT00916474

Last Updated: 2014-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

408 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A

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

telaprevir

Intervention Type DRUG

Cohort B

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

telaprevir

Intervention Type DRUG

Interventions

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telaprevir

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tibotec Pharmaceutical Limited

INDUSTRY

Sponsor Role collaborator

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Vertex Pharmaceuticals Incorporated

Locations

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Alabama

Birmingham, Alabama, United States

Site Status

California

Coronado, California, United States

Site Status

California

Los Angeles, California, United States

Site Status

California

San Francisco, California, United States

Site Status

Colorado

Denver, Colorado, United States

Site Status

Colorado

Englewood, Colorado, United States

Site Status

Florida

Gainsville, Florida, United States

Site Status

Florida

Jacksonville, Florida, United States

Site Status

Florida

Miami, Florida, United States

Site Status

Georgia

Altanta, Georgia, United States

Site Status

Maryland

Baltimore, Maryland, United States

Site Status

Massachusetts

Boston, Massachusetts, United States

Site Status

Michigan

Novi, Michigan, United States

Site Status

Missouri

St Louis, Missouri, United States

Site Status

New Mexico

Albuquerque, New Mexico, United States

Site Status

New York

Manhasset, New York, United States

Site Status

New York

New York, New York, United States

Site Status

North Carolina

Chapel Hill, North Carolina, United States

Site Status

North Carolina

Durham, North Carolina, United States

Site Status

Ohio

Cincinnati, Ohio, United States

Site Status

South Carolina

Columbia, South Carolina, United States

Site Status

Texas

Houston, Texas, United States

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Texas

San Antonio, Texas, United States

Site Status

Virginia

Fairfax, Virginia, United States

Site Status

Virginia

Falls Church, Virginia, United States

Site Status

Canada

Vancouver, British Columbia, Canada

Site Status

Canada

Toronto, Ontario, Canada

Site Status

France

Clichy, , France

Site Status

France

Marseille, , France

Site Status

France

Paris, , France

Site Status

France

Pessac, , France

Site Status

France

Vandœuvre-lès-Nancy, , France

Site Status

Germany

Berlin, , Germany

Site Status

Germany

Cologne, , Germany

Site Status

Germany

Frankfurt, , Germany

Site Status

Germany

Freiburg im Breisgau, , Germany

Site Status

Germany

Hamburg, , Germany

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Germany

Hanover, , Germany

Site Status

Germany

Munich, , Germany

Site Status

Germany

Wien, , Germany

Site Status

Puerto Rico

Santurce, , Puerto Rico

Site Status

Countries

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United States Canada France Germany Puerto Rico

Other Identifiers

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VX08-950-112

Identifier Type: -

Identifier Source: org_study_id

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