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

Phase 1

Completed

• Conditions: Evidence of Liver Transplantation; Hepatitis C
• Interventions: Drug: ITX 5061

• Registration Number: NCT01292824
• Lead Sponsor: University of Birmingham

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Primary Completion: 2013-01
• Study Completion: 2013-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ITX 5061	ITX 5061	Liver Transplantation as per Standard of Care + ITX5061

Primary Outcome Measures

Name	Time	Method
To determine the safety of ITX 5061 in liver transplant recipients	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 Outcome Measures

Name	Time	Method
To determine whether any change in early viral kinetics is sustained	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.
To determine whether treatment leads to an alteration in HCV RNA kinetics in the first week after liver transplantation	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.

Trial Locations

Locations (1)

University Hospital Birmingham; 🇬🇧 Birmingham, West Midlands, United Kingdom