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

Last updated: March 18, 2019
Sponsor: Martin Janičko
Overall Status: Active - Recruiting

Phase

2/3

Condition

Liver Failure

Liver Disorders

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT02837939
IMUNO - HEGITO 7
  • Ages > 18
  • All Genders

Study 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..

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • admission to hospital at participating liver units or ICUs or internal medicine wardswith acute decompensation (AD) of advanced chronic liver disease or acute-on-chronicliver failure according to CLIF - C criteria

  • ability to provide informed consent,

Exclusion

Exclusion Criteria:

  • disapproval

  • lymphoproliferative disorders

  • liver transplantation in the past

  • pregnancy

  • suspected. chronic infection in risk locations

  • CNS

  • peritoneum

  • Known virus-related immune deficiency

  • malignancy

  • severe heart failure (NYHA >= III)

  • severe lung disease (COPD, GOLD>3)

Study Design

Total Participants: 124
Study Start date:
July 01, 2016
Estimated Completion Date:
July 31, 2020

Study 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.

Connect with a study center

  • F.D.Roosevelt Teaching Hospital with policlinic Banska Bystrica

    Banska Bystrica, 97517
    Slovakia

    Active - Recruiting

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