NCT02837939

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

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

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Martin Janičko · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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..

Detailed 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.

Conditions

• Cirrhosis
• Liver Failure

Interventions

Type	Name	Description
DRUG	Human derived Transfer factor	One dose (the content of one amp.) of lyophilised drug contains: Leucocyte dialysatum 200 x 10 to the power of 6 (Lyophilized dialysate from 200 million leukocytes) pH = 7.8 to 9 after reconstitution (dissolving) of drug To be administered subcutaneously as follows: 12 doses TF in total: * 3 x TF in first week: day 1,3,5 * 2 x TF in week 2: day 8 , 11 * 1 xTF in week 3 and 4 : day 15, 22 * 1 x TF once a month up to 6 month
DRUG	Aqua pro injectione 4ml ampules for subcutaneous injection	12 doses in total: * 3 doses in first week: day 1,3,5 * 2 doses in week 2: day 8 , 11 * 1 dose in week 3 and 4 : day 15, 22 * 1 dose once a month up to 6 month

Timeline

• Start date: 2016-07-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2016-07-20
• Last updated: 2023-11-18

Locations

1 site across 1 country: Slovakia