Study of Telaprevir in Subjects With Hepatic Impairment
Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00509210
Collaborator
(none)
1
9
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Study Start Date
:
Sep 1, 2007
Actual Primary Completion Date
:
Jun 1, 2008
Actual Study Completion Date
:
Jun 1, 2008
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00509210
Other Study ID Numbers:
- VX06-950-012
First Posted:
Jul 31, 2007
Last Update Posted:
Oct 29, 2008
Last Verified:
Oct 1, 2008
Keywords provided by ,
,
Additional relevant MeSH terms: