NCT00509210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

October 29, 2008

Status Verified

October 1, 2008

Enrollment Period

9 months

First QC Date

July 30, 2007

Last Update Submit

October 28, 2008

Conditions

Hepatic Insufficiency

Keywords

Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

Interventions

telaprevir (VX-950)DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosed with Child Pugh score of 7-9 or greater than 10
  • Women of non-childbearing age

You may not qualify if:

  • Tested positive for HIV, Hepatitis C, Hepatitis B

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Hepatic InsufficiencyLiver Diseases

Interventions

telaprevir

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Paul Y Kwo, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 30, 2007

First Posted

July 31, 2007

Study Start

September 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

October 29, 2008

Record last verified: 2008-10

Locations

US(1)