Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection|
- To determine the safety of ITX 5061 in liver transplant recipients [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
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
- To determine whether treatment leads to an alteration in HCV RNA kinetics in the first week after liver transplantation [ Time Frame: One week ] [ Designated as safety issue: No ]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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]Hepatitis C virus titers will be measured at multiple times in the post-operative period and kinetics assessed at 90 days after liver transplant.
|Study Start Date:||February 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|No Intervention: Standard liver transplant care|
|Experimental: ITX 5061||
Drug: ITX 5061
ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292824
|University Hospital Birmingham|
|Birmingham, West Midlands, United Kingdom, B15 2TH|
|Principal Investigator:||David J Mutimer, FRCP||University of Birmingham|