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Study of Telaprevir in Subjects With Hepatic Impairment

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00509210
Enrollment
Unknown
Registered
2007-07-31
Start date
2007-09-30
Completion date
2008-06-30
Last updated
2008-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Insufficiency

Keywords

Liver Disease

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.

Interventions

DRUGtelaprevir (VX-950)

Sponsors

Vertex Pharmaceuticals Incorporated
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026