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

Martin Janičko

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Cirrhosis; Liver Failure

Treatments: Drug: Human derived Transfer factor; Drug: Aqua pro injectione 4ml ampules for subcutaneous injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02837939

IMUNO - HEGITO 7

Details and patient eligibility

About

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..

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• admission to hospital at participating liver units or ICUs or internal medicine wards with acute decompensation (AD) of advanced chronic liver disease or acute-on-chronic liver failure according to CLIF - C criteria
• ability to provide informed consent,

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Drug: Human derived Transfer factor applied by subcutaneous injection in specified time points.

Treatment:

Drug: Human derived Transfer factor

Control

Placebo Comparator group

Description:

Aqua pro injectione 4 mL ampules for subcutaneous administration in the same time points as in the active arm

Treatment:

Drug: Aqua pro injectione 4ml ampules for subcutaneous injection