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| Name | Class |
|---|---|
| F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Drug: Human derived Transfer factor applied by subcutaneous injection in specified time points. |
|
| Control | Placebo Comparator | Aqua pro injectione 4 mL ampules for subcutaneous administration in the same time points as in the active arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human derived Transfer factor | Drug | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint that includes the incidence specified infections: |
| Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | The length of hospital stay after the admission with diagnosed infection or contraction of infection during hospital stay | Two years |
| The usage of antibiotics required for treatment of a diagnosed infection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the phagocytic activity of macrophages | 6 months | |
| Changes in the levels of imunoglobulins IgA, IgG, IgM, IgD, IgE | 6 months | |
| Changes in the capacity for oxidative burst in macrophages |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lubomir Skladany, MD, PhD | F.D.Roosevelt Teaching Hospital with policlinic, Banska Bystrica, Slovakia, 97517 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| F.D.Roosevelt Teaching Hospital with policlinic Banska Bystrica | Banská Bystrica | 97517 | Slovakia |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D007279 | Injections, Subcutaneous |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
|
| Aqua pro injectione 4ml ampules for subcutaneous injection | Drug | 12 doses in total:
|
|
| Two years |
| The incidence of adverse effects | 2 years |
| 6 months |
| Changes in the complement levels and activation pathways activity | 6 months |
| Changes in lymphocyte subpopulations | 6 months |
| Changes in the levels of immunomodulators - IL-6, TNF alpha | 6 months |
| D004066 | Digestive System Diseases |