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

University of Birmingham

Status and phase: Completed; Phase 1

Conditions: Evidence of Liver Transplantation; Hepatitis C

Treatments: Drug: ITX 5061

Study type: Interventional

Funder types: Other

Identifiers

NCT01292824

2010-020358-32 (EudraCT Number)

RG_10-104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Standard liver transplant care

No Intervention group

Description:

Liver Transplantation as per Standard of Care

ITX 5061

Experimental group

Description:

Liver Transplantation as per Standard of Care + ITX5061

Treatment:

Drug: ITX 5061