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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
  Purpose
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 Intervention Phase
Hepatic Insufficiency Drug: telaprevir (VX-950) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Pharmacokinetics

Study Start Date: September 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00509210


Locations
United States, Indiana
Indiana University, Department of Medicine,Division of Gastroenterology / Hepatology
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Principal Investigator: Paul Y Kwo, MD Indiana University, Department of Medicine, Division of Gastroenterology/Hepatology
  More Information

ClinicalTrials.gov Identifier: NCT00509210     History of Changes
Other Study ID Numbers: VX06-950-012
First Submitted: July 30, 2007
First Posted: July 31, 2007
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