Study of Telaprevir in Subjects With Hepatic Impairment

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. Identifier: NCT00509210
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : October 29, 2008
Information provided by:
Vertex Pharmaceuticals Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatic Insufficiency Drug: telaprevir (VX-950) Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : September 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Primary Outcome Measures :
  1. Pharmacokinetics

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00509210

United States, Indiana
Indiana University, Department of Medicine,Division of Gastroenterology / Hepatology
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Principal Investigator: Paul Y Kwo, MD Indiana University, Department of Medicine, Division of Gastroenterology/Hepatology Identifier: NCT00509210     History of Changes
Other Study ID Numbers: VX06-950-012
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: October 29, 2008
Last Verified: October 2008

Keywords provided by Vertex Pharmaceuticals Incorporated:
Liver Disease

Additional relevant MeSH terms:
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases