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

Cirrhosis Clinical Trial

— IMUNO-HEGITO7  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02837939
• Other study ID #: IMUNO - HEGITO 7
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: July 2016
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: Pavol Jozef Safarik University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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..

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
Slovakia	F.D.Roosevelt Teaching Hospital with policlinic Banska Bystrica	Banska Bystrica

Sponsors (2)

Lead Sponsor	Collaborator
Martin Janicko	F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the phagocytic activity of macrophages		6 months
Other	Changes in the levels of imunoglobulins IgA, IgG, IgM, IgD, IgE		6 months
Other	Changes in the capacity for oxidative burst in macrophages		6 months
Other	Changes in the complement levels and activation pathways activity		6 months
Other	Changes in lymphocyte subpopulations		6 months
Other	Changes in the levels of immunomodulators - IL-6, TNF alpha		6 months
Primary	Composite endpoint that includes the incidence specified infections:	Spontaneous bacterial peritonitis; Urinary tract infections: Pneumonia; Skin and soft tissue infections; Spontaneous bacteremia; Endocarditis; Tuberculosis; Infectious colitis	Two years
Secondary	Length of hospital stay	The length of hospital stay after the admission with diagnosed infection or contraction of infection during hospital stay	Two years
Secondary	The usage of antibiotics required for treatment of a diagnosed infection		Two years
Secondary	The incidence of adverse effects		2 years