Back to resultsStudy of Telaprevir in Subjects With Hepatic Impairment
Primary Purpose
Hepatic Insufficiency
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
telaprevir (VX-950)
Sponsored by
About this trial
This is an interventional basic science trial for Hepatic Insufficiency focused on measuring Liver Disease
Eligibility 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
Sites / Locations
- Indiana University, Department of Medicine,Division of Gastroenterology / Hepatology
Outcomes
Primary Outcome Measures
Pharmacokinetics
Secondary Outcome Measures
Full Information
NCT ID
NCT00509210
First Posted
July 30, 2007
Last Updated
October 28, 2008
Sponsor
Vertex Pharmaceuticals Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00509210
Brief Title
Study of Telaprevir in Subjects With Hepatic Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vertex Pharmaceuticals Incorporated
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Insufficiency
Keywords
Liver Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
telaprevir (VX-950)
Primary Outcome Measure Information:
Title
Pharmacokinetics
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Y Kwo, MD
Organizational Affiliation
Indiana University, Department of Medicine, Division of Gastroenterology/Hepatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University, Department of Medicine,Division of Gastroenterology / Hepatology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Telaprevir in Subjects With Hepatic Impairment
We'll reach out to this number within 24 hrs