Study of Telaprevir in Subjects With Hepatic Impairment
Phase 1
Completed
- Conditions
- Hepatic Insufficiency
- Registration Number
- NCT00509210
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Pharmacokinetics
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Indiana University, Department of Medicine,Division of Gastroenterology / Hepatology
🇺🇸Indianapolis, Indiana, United States
Indiana University, Department of Medicine,Division of Gastroenterology / Hepatology🇺🇸Indianapolis, Indiana, United States