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

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ClinicalTrials.gov Identifier: NCT02837939
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Information provided by (Responsible Party):
Martin Janičko, Pavol Jozef Safarik University

Study Description
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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..

Condition or disease Intervention/treatment Phase
Cirrhosis Liver Failure Drug: Human derived Transfer factor Drug: Aqua pro injectione 4ml ampules for subcutaneous injection Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Prospective Randomized Single-blind Study on Transfer-factor in Acute Decompensation of Advanced Chronic Liver Disease and Acute-on-chronic Liver Failure.
Study Start Date : July 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Active
Drug: Human derived Transfer factor applied by subcutaneous injection in specified time points.
 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
Other Name: IMMODIN. Holder: IMUNA PHARM a.s. - GRIFOLS (SVK) Registration number: 59/0147/89-CS
Placebo Comparator: Control
Aqua pro injectione 4 mL ampules for subcutaneous administration in the same time points as in the active arm
 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


Outcome Measures
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Primary Outcome Measures :
  1. Composite endpoint that includes the incidence specified infections: [ Time Frame: Two years ]
    1. 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 Outcome Measures :
  1. 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

  2. The usage of antibiotics required for treatment of a diagnosed infection [ Time Frame: Two years ]
  3. The incidence of adverse effects [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Change in the phagocytic activity of macrophages [ Time Frame: 6 months ]
  2. Changes in the levels of imunoglobulins IgA, IgG, IgM, IgD, IgE [ Time Frame: 6 months ]
  3. Changes in the capacity for oxidative burst in macrophages [ Time Frame: 6 months ]
  4. Changes in the complement levels and activation pathways activity [ Time Frame: 6 months ]
  5. Changes in lymphocyte subpopulations [ Time Frame: 6 months ]
  6. Changes in the levels of immunomodulators - IL-6, TNF alpha [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837939


Contacts
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Contact: Lubomir Skladany, MD, PhD +421484412135 lubomir.skladany@gmail.com
Contact: Jana Vnencakova, PhDr +421484412685 jvnencakova@nspbb.sk

Locations
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Slovakia
F.D.Roosevelt Teaching Hospital with policlinic Banska Bystrica Recruiting
Banska Bystrica, Slovakia, 97517
Contact: Svetlana Adamcova Selcanova, MD    +42148441 ext 2135    hepato@nspbb.sk   
Sponsors and Collaborators
Martin Janičko
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Investigators
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Principal Investigator: Lubomir Skladany, MD, PhD F.D.Roosevelt Teaching Hospital with policlinic, Banska Bystrica, Slovakia, 97517
More Information
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Responsible Party: Martin Janičko, Assistant Professor of Medicine, Faculty of Medicine, Pavol Jozef Safarik University
ClinicalTrials.gov Identifier: NCT02837939    
Other Study ID Numbers: IMUNO - HEGITO 7
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Failure
Hepatic Insufficiency
Fibrosis
 Pathologic Processes
Liver Diseases
Digestive System Diseases