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Study of Telaprevir in Subjects With Hepatic Impairment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00509210
First Posted: July 31, 2007
Last Update Posted: October 29, 2008
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.
Information provided by:
Vertex Pharmaceuticals Incorporated
July 30, 2007
July 31, 2007
October 29, 2008
September 2007
June 2008   (Final data collection date for primary outcome measure)
Pharmacokinetics
Same as current
Complete list of historical versions of study NCT00509210 on ClinicalTrials.gov Archive Site
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Study of Telaprevir in Subjects With Hepatic Impairment
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The purpose of this study is to assess the safety and pharmacokinetics of Telaprevir following administration of multiple oral doses to subjects with moderate and severe hepatic impairment.
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Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Hepatic Insufficiency
Drug: telaprevir (VX-950)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2008
June 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinically diagnosed with Child Pugh score of 7-9 or greater than 10
  • Women of non-childbearing age

Exclusion Criteria:

  • Tested positive for HIV, Hepatitis C, Hepatitis B
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00509210
VX06-950-012
Yes
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Vertex Pharmaceuticals Incorporated
Not Provided
Principal Investigator: Paul Y Kwo, MD Indiana University, Department of Medicine, Division of Gastroenterology/Hepatology
Vertex Pharmaceuticals Incorporated
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP