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

February 9, 2011
October 10, 2013
February 2011
January 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01292824 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • Evidence of Liver Transplantation
Drug: ITX 5061
ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week.
  • No Intervention: Standard liver transplant care
  • Experimental: ITX 5061
    Intervention: Drug: ITX 5061
Syder AJ, Lee H, Zeisel MB, Grove J, Soulier E, Macdonald J, Chow S, Chang J, Baumert TF, McKeating JA, McKelvy J, Wong-Staal F. Small molecule scavenger receptor BI antagonists are potent HCV entry inhibitors. J Hepatol. 2011 Jan;54(1):48-55. Epub 2010 Aug 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01292824
RG_10-104, 2010-020358-32
No
Matthew Armstrong, University of Birmingham
University of Birmingham
  • University Hospital Birmingham
  • National Institute for Health Research, United Kingdom
Principal Investigator: David J Mutimer, FRCP University of Birmingham
University of Birmingham
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP