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

Primary Purpose

Hepatitis C, Evidence of Liver Transplantation

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
ITX 5061
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C virus, Entry, Scavenger receptor-BI, High density lipoprotein, Liver transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard liver transplant care

ITX 5061

Arm Description

Liver Transplantation as per Standard of Care

Liver Transplantation as per Standard of Care + ITX5061

Outcomes

Primary Outcome Measures

To determine the safety of ITX 5061 in liver transplant recipients
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
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
Hepatitis C virus titers will be measured at multiple times in the post-operative period and kinetics assessed at 90 days after liver transplant.

Full Information

First Posted
February 9, 2011
Last Updated
December 1, 2015
Sponsor
University of Birmingham
Collaborators
University Hospital Birmingham, National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT01292824
Brief Title
Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients
Acronym
ITX5061
Official Title
Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Birmingham
Collaborators
University Hospital Birmingham, National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Evidence of Liver Transplantation
Keywords
Hepatitis C virus, Entry, Scavenger receptor-BI, High density lipoprotein, Liver transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard liver transplant care
Arm Type
No Intervention
Arm Description
Liver Transplantation as per Standard of Care
Arm Title
ITX 5061
Arm Type
Experimental
Arm Description
Liver Transplantation as per Standard of Care + ITX5061
Intervention Type
Drug
Intervention Name(s)
ITX 5061
Intervention Description
ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week.
Primary Outcome Measure Information:
Title
To determine the safety of ITX 5061 in liver transplant recipients
Description
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
Time Frame
90 days
Secondary Outcome Measure Information:
Title
To determine whether treatment leads to an alteration in HCV RNA kinetics in the first week after liver transplantation
Description
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.
Time Frame
One week
Title
To determine whether any change in early viral kinetics is sustained
Description
Hepatitis C virus titers will be measured at multiple times in the post-operative period and kinetics assessed at 90 days after liver transplant.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Mutimer, FRCP
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Birmingham
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20932595
Citation
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. doi: 10.1016/j.jhep.2010.06.024. Epub 2010 Aug 21.
Results Reference
background
PubMed Identifier
26437376
Citation
Rowe IA, Tully DC, Armstrong MJ, Parker R, Guo K, Barton D, Morse GD, Venuto CS, Ogilvie CB, Hedegaard DL, McKelvy JF, Wong-Staal F, Allen TM, Balfe P, McKeating JA, Mutimer DJ. Effect of scavenger receptor class B type I antagonist ITX5061 in patients with hepatitis C virus infection undergoing liver transplantation. Liver Transpl. 2016 Mar;22(3):287-97. doi: 10.1002/lt.24349.
Results Reference
result

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

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