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Study of Telaprevir in Subjects With Hepatic Impairment

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00509210
First received: July 30, 2007
Last updated: October 28, 2008
Last verified: October 2008

July 30, 2007
October 28, 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
Not Provided

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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
Not Provided
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00509210
VX06-950-012
Yes
Not Provided
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