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

This study has been completed.
Sponsor:
Collaborators:
University Hospital Birmingham
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Matthew Armstrong, University of Birmingham
ClinicalTrials.gov Identifier:
NCT01292824
First received: February 9, 2011
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Evidence of Liver Transplantation
Drug: ITX 5061
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection

Resource links provided by NLM:


Further study details as provided by University of Birmingham:

Primary Outcome Measures:
  • To determine the safety of ITX 5061 in liver transplant recipients [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • To determine whether treatment leads to an alteration in HCV RNA kinetics in the first week after liver transplantation [ Time Frame: One week ] [ Designated as safety issue: No ]
    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.

  • To determine whether any change in early viral kinetics is sustained [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Hepatitis C virus titers will be measured at multiple times in the post-operative period and kinetics assessed at 90 days after liver transplant.


Enrollment: 24
Study Start Date: February 2011
Study Completion Date: May 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard liver transplant care
Experimental: ITX 5061 Drug: ITX 5061
ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292824

Locations
United Kingdom
University Hospital Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TH
Sponsors and Collaborators
University of Birmingham
University Hospital Birmingham
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: David J Mutimer, FRCP University of Birmingham
  More Information

Publications:
Responsible Party: Matthew Armstrong, Professor Dr Mutimer, University of Birmingham
ClinicalTrials.gov Identifier: NCT01292824     History of Changes
Other Study ID Numbers: RG_10-104, 2010-020358-32
Study First Received: February 9, 2011
Last Updated: October 10, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Birmingham:
Hepatitis C virus
Entry
Scavenger receptor-BI
High density lipoprotein
Liver transplantation

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 22, 2014