Study of Telaprevir in Subjects With Hepatic Impairment

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hepatic Insufficiency

Treatments: Drug: telaprevir (VX-950)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00509210

VX06-950-012

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)