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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Withdrawn
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02837939
Acronym
IMUNO-HEGITO7
Enrollment
0
Registered
2016-07-20
Start date
2016-07-31
Completion date
2025-07-31
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver Failure

Brief 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.

Interventions

DRUGHuman 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

DRUGAqua 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

Sponsors

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
CollaboratorOTHER
Martin Janičko
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Composite endpoint that includes the incidence specified infections:Two years1. Spontaneous bacterial peritonitis 2. Urinary tract infections: 3. Pneumonia 4. Skin and soft tissue infections 5. Spontaneous bacteremia 6. Endocarditis 7. Tuberculosis 8. Infectious colitis

Secondary

MeasureTime frameDescription
Length of hospital stayTwo yearsThe length of hospital stay after the admission with diagnosed infection or contraction of infection during hospital stay
The usage of antibiotics required for treatment of a diagnosed infectionTwo years
The incidence of adverse effects2 years

Other

MeasureTime frame
Changes in lymphocyte subpopulations6 months
Change in the phagocytic activity of macrophages6 months
Changes in the levels of immunomodulators - IL-6, TNF alpha6 months
Changes in the levels of imunoglobulins IgA, IgG, IgM, IgD, IgE6 months
Changes in the capacity for oxidative burst in macrophages6 months
Changes in the complement levels and activation pathways activity6 months

Countries

Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026