Transfer Factor Efficacy in the Management of Cirrhosis-associated Immune Dysfunction (IMUNO-HEGITO7)
Prospective Randomized Single-blind Study on Transfer-factor in Acute Decompensation of Advanced Chronic Liver Disease and Acute-on-chronic Liver Failure.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Banska Bystrica, Slovakia, 97517
- F.D.Roosevelt Teaching Hospital with policlinic Banska Bystrica
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Active
Drug: Human derived Transfer factor applied by subcutaneous injection in specified time points.
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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:
Other Names:
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Placebo Comparator: Control
Aqua pro injectione 4 mL ampules for subcutaneous administration in the same time points as in the active arm
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12 doses in total:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite endpoint that includes the incidence specified infections:
Time Frame: Two years
|
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Two years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of hospital stay
Time Frame: Two years
|
The length of hospital stay after the admission with diagnosed infection or contraction of infection during hospital stay
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Two years
|
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The usage of antibiotics required for treatment of a diagnosed infection
Time Frame: Two years
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Two years
|
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The incidence of adverse effects
Time Frame: 2 years
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2 years
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in the phagocytic activity of macrophages
Time Frame: 6 months
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6 months
|
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Changes in the levels of imunoglobulins IgA, IgG, IgM, IgD, IgE
Time Frame: 6 months
|
6 months
|
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Changes in the capacity for oxidative burst in macrophages
Time Frame: 6 months
|
6 months
|
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Changes in the complement levels and activation pathways activity
Time Frame: 6 months
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6 months
|
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Changes in lymphocyte subpopulations
Time Frame: 6 months
|
6 months
|
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Changes in the levels of immunomodulators - IL-6, TNF alpha
Time Frame: 6 months
|
6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lubomir Skladany, MD, PhD, F.D.Roosevelt Teaching Hospital with policlinic, Banska Bystrica, Slovakia, 97517
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMUNO - HEGITO 7
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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