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NCT00509210 Clinical Trial

Study of Telaprevir in Subjects With Hepatic Impairment

Hepatic Insufficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00509210
Other study ID # VX06-950-012
Secondary ID
Status Completed
Phase Phase 1
First received July 30, 2007
Last updated October 28, 2008
Start date September 2007
Est. completion date June 2008

Study information
Verified date October 2008
Source Vertex Pharmaceuticals Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• telaprevir (VX-950)

Locations
Country Name City State
United States Indiana University, Department of Medicine,Division of Gastroenterology / Hepatology Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics
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