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
  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: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00509210     History of Changes
Other Study ID Numbers: VX06-950-012
Study First Received: July 30, 2007
Last Updated: October 28, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Vertex Pharmaceuticals Incorporated:
Liver Disease

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

ClinicalTrials.gov processed this record on August 18, 2014