Hepatitis C Clinical Trial
Official title:
Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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