Study of Telaprevir in Subjects With Hepatic Impairment | NCT00509210 | Trialant
CompletedInterventionalPhase 1Updated Oct 29, 2008
Study of Telaprevir in Subjects With Hepatic Impairment
ClinicalTrials.gov ID
NCT00509210
Lead Sponsor
Vertex Pharmaceuticals IncorporatedINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Last Update Posted
Oct 29, 2008Estimated
Start Date
Sep 2007
Primary Completion Date
Jun 2008Actual
Completion Date
Jun 2008Actual
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.
Hepatic Insufficiency
telaprevir (VX-950)
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
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
Primary Purpose
Basic Science
Allocation
Non-Randomized
Interventional Model
Single Group Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
Indiana University, Department of Medicine,Division of Gastroenterology / Hepatology