Transfer Factor Efficacy in the Management of Cirrhosis-associated Immune Dysfunction — IMUNO-HEGITO7  

Cirrhosis Clinical Trial

Official title: Prospective Randomized Single-blind Study on Transfer-factor in Acute Decompensation of Advanced Chronic Liver Disease and Acute-on-chronic Liver Failure.

Status Withdrawn

Clinical Trial Summary

This study is aimed to assess the efficacy of Human derived Transfer factor ( T-lymphocytes homogenate that contains small molecular weight (10 kDa) molecules: various IFNs, ILs, chemokines, endorfins, heat shock proteins) in decreasing rate and/or severity of infections in acute or chronic decompensations of liver cirrhosis and acute on chronic liver failure..

Clinical Trial Description

Most of mortality from advanced chronic liver disease (ACLD) is mediated by so- called specific complications of end-stage liver disease (ESLD); one of the most important is infection (25-30%). Infection is responsible for considerable proportion of ESLD-related mortality. Important in pathogenesis of infections in ESLD is CAIDS (cirrhosis - associated immune dysfunction syndrome), recently re-named to CAID (Cirrhosis-Associated Immune Deficit). TRANSFER FACTOR (TF) is supposed to act at several points in CAID - cascade. This gave rise to hypothesis, that TF could be of benefit in AD/ACLF.

Characteristics of TF It has been shown that transmission fo T-Lymphocyte reactivity is transmissible not only by T-cells alone, but also by hommogenate of peripheral white blood cells. Later it became clear that for the transmission of cellular immunity is responsible dialysable fraction of T-lymphocytes homogenate (with small molecular weight of 10 kDa; consists of amino acids, small peptides, nucleotides etc). This homogenate was named Transfer

• factor (TF). One dose of lyophilized drug contains: Leucocyti dialysatum 200 x 10 6 (contains various IFNs, ILs, chemokines, endorfins, heat shock protein etc)

• stimulates T H 1 response

• induces production of IL-1, IL-2

• activates chemotaxis of immunocompetent cells

• increases fagocytic activity

• activates antigen-presentation by APCs

The aim of this study is to assess the efficacy of transfer factor in decreasing rate and/or severity of infections in ACLF. ;

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hepatic Insufficiency
• Liver Cirrhosis
• Liver Failure

• NCT number: NCT02837939
• Study type: Interventional
• Source: Pavol Jozef Safarik University
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: July 2016
• Completion date: July 2025