A Phase 2/3 interventional study of Human derived Transfer factor and Aqua pro injectione 4ml ampules for subcutaneous injection in Cirrhosis and Liver Failure, sponsored by Martin Janičko. Withdrawn at 1 site in Slovakia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Martin Janičko · Phase 2/3, Interventional, and Prevention
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..
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)
The aim of this study is to assess the efficacy of transfer factor in decreasing rate and/or severity of infections in ACLF.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
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Exclusion Criteria:
Drug: Human derived Transfer factor applied by subcutaneous injection in specified time points.
Drug: Human derived Transfer factor
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
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
Also known as: IMMODIN. Holder: IMUNA PHARM a.s. - GRIFOLS (SVK) Registration number: 59/0147/89-CS
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
Composite endpoint that includes the incidence specified infections:
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
Time frame: Two years
Length of hospital stay
The length of hospital stay after the admission with diagnosed infection or contraction of infection during hospital stay
Time frame: Two years
The usage of antibiotics required for treatment of a diagnosed infection
Time frame: Two years
The incidence of adverse effects
Time frame: 2 years
Change in the phagocytic activity of macrophages
Time frame: 6 months
Changes in the levels of imunoglobulins IgA, IgG, IgM, IgD, IgE
Time frame: 6 months
Changes in the capacity for oxidative burst in macrophages
Time frame: 6 months
Changes in the complement levels and activation pathways activity
Time frame: 6 months
Changes in lymphocyte subpopulations
Time frame: 6 months
Changes in the levels of immunomodulators - IL-6, TNF alpha
Time frame: 6 months
This study is withdrawn, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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