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Completed

NCT Number: NCT01292824

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Evidence of Liver Transplantation Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ITX 5061

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • National Institute for Health Research, United Kingdom
  • University Hospital Birmingham

Registry information

Official study title

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

Acronym: ITX5061

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 10, 2011
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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