Study of Telaprevir in Subjects With Hepatic Impairment

Vertex Pharmaceuticals Incorporated

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Hepatic Insufficiency

Interventions

telaprevir (VX-950)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Pharmacokinetics

Data from ClinicalTrials.gov

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