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Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients

NCT01292824 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-12-03

No results posted yet for this study

Summary

This is a phase I pilot study to determine the safety and preliminary efficacy of a novel hepatitis C virus (HCV) entry inhibitor (ITX 5061) in patients with HCV infection undergoing liver transplantation.

Conditions

  • Hepatitis C
  • Evidence of Liver Transplantation

Interventions

DRUG

ITX 5061

ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week.

Sponsors & Collaborators

  • University Hospital Birmingham

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Birmingham

    lead OTHER

Principal Investigators

  • David J Mutimer, FRCP · University of Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-01-31
Completion
2013-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01292824 on ClinicalTrials.gov