Study of Telaprevir in Subjects With Hepatic Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-06-30

Brief Summary

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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

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Conditions

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Hepatic Insufficiency

Keywords

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Liver Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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telaprevir (VX-950)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Paul Y Kwo, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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VX06-950-012

Identifier Type: -

Identifier Source: org_study_id