Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Birmingham
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- To determine the safety of ITX 5061 in liver transplant recipients
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ITX 5061
Liver Transplantation as per Standard of Care + ITX5061
Intervention: ITX 5061 (Drug)
Outcomes
Primary Outcomes
To determine the safety of ITX 5061 in liver transplant recipients
Time Frame: 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 Outcomes
- To determine whether any change in early viral kinetics is sustained(90 days)
- To determine whether treatment leads to an alteration in HCV RNA kinetics in the first week after liver transplantation(One week)