Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients (ITX5061)

December 1, 2015 updated by: University of Birmingham

Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hepatitis C virus (HCV) infection is common and treatment options at present are limited. Recurrence of HCV infection after liver transplantation is inevitable and disease progression is rapid when compared with disease in the non-transplanted liver.

Studies of ITX 5061 in vitro have shown it to be a potent inhibitor of HCV entry into hepatocytes, through blocking the interaction of the virus with scavenger receptor BI suggesting it may reduce graft re-infection rates after liver transplant.

There are no studies of treatments to block host receptors for HCV and the investigators hypothesize that ITX 5061 will modulate HCV kinetics in the early phase post liver transplant.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • University Hospital Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years old, ≤ 65 years old
  • Plasma HCV RNA positive at time of listing for liver transplantation
  • Accepted for liver transplantation for any of:
  • End-stage liver disease due to HCV infection
  • End-stage liver disease due to HCV infection and alcohol related liver disease (ALD)
  • HCC due to HCV

Exclusion Criteria:

  • Refusal or inability to give informed consent
  • Viral co-infection with either hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Pregnancy or breastfeeding
  • Women, of child-bearing potential, who are not willing to practice effective contraception
  • Men, sexually active with women of child-bearing potential, who are not willing to practice effective contraception
  • Any situation that in the Investigator's opinion may interfere with optimal study participation
  • Participation in any clinical study of an investigational agent within 30 days of recruitment
  • Transplantation with a donor organ from a HCV positive individual

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Standard liver transplant care
Liver Transplantation as per Standard of Care
EXPERIMENTAL: ITX 5061
Liver Transplantation as per Standard of Care + ITX5061
Drug: ITX 5061
ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the safety of ITX 5061 in liver transplant recipients
Time Frame: 90 days

Safety will be assessed by determination of the frequency of:

  • perioperative events: including transfusion requirements and vasopressor requirements
  • post-operative events: including primary graft non-function, hepatic artery thrombosis, acute cellular rejection and infective complications
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine whether treatment leads to an alteration in HCV RNA kinetics in the first week after liver transplantation
Time Frame: One week
Hepatitis C virus titers will be measured at multiple times in the peri- and immediate post-operative period and kinetics assessed at 7 days after liver transplant.
One week
To determine whether any change in early viral kinetics is sustained
Time Frame: 90 days
Hepatitis C virus titers will be measured at multiple times in the post-operative period and kinetics assessed at 90 days after liver transplant.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

National Institute for Health Research, United Kingdom
University Hospital Birmingham

Investigators

  • Principal Investigator: David J Mutimer, FRCP, University of Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 9, 2011

First Posted (ESTIMATE)

February 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG_10-104
  • 2010-020358-32 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C

Clinical Trials on ITX 5061

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe