Study of Telaprevir in Subjects With Hepatic Impairment

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ClinicalTrials.gov Identifier: NCT00509210

Recruitment Status : Completed

First Posted : July 31, 2007

Last Update Posted : October 29, 2008

Sponsor:

Information provided by:

Vertex Pharmaceuticals Incorporated

Tracking Information

First Submitted Date ^ICMJE

July 30, 2007

First Posted Date ^ICMJE

July 31, 2007

Last Update Posted Date

October 29, 2008

Study Start Date ^ICMJE

September 2007

Actual Primary Completion Date

June 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacokinetics

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00509210 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Telaprevir in Subjects With Hepatic Impairment

Official Title ^ICMJE

Not Provided

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Condition ^ICMJE

Hepatic Insufficiency

Intervention ^ICMJE

Drug: telaprevir (VX-950)

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date

June 2008

Actual Primary Completion Date

June 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00509210

Other Study ID Numbers ^ICMJE

VX06-950-012

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Vertex Pharmaceuticals Incorporated

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Paul Y Kwo, MD

Indiana University, Department of Medicine, Division of Gastroenterology/Hepatology

PRS Account

Vertex Pharmaceuticals Incorporated

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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