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

University of Birmingham24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Evidence of Liver Transplantation

Interventions

ITX 5061DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Birmingham

Birmingham, West Midlands, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 90 days

Secondary Outcomes

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.

Time frame: One week

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.

Time frame: 90 days

Data from ClinicalTrials.gov

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