Prospective Randomized Single-blind Study on Transfer-factor in Acute Decompensation of Advanced Chronic Liver Disease and Acute-on-chronic Liver Failure.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Composite endpoint that includes the incidence specified infections:
研究概览
简要总结
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..
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
排除标准
- •disapproval
- •lymphoproliferative disorders
- •liver transplantation in the past
- •pregnancy
- •suspected. chronic infection in risk locations
- •peritoneum
- •Known virus-related immune deficiency
- •malignancy
- •severe heart failure (NYHA >= III)
- •severe lung disease (COPD, GOLD>3)
研究组 & 干预措施
Active
Drug: Human derived Transfer factor applied by subcutaneous injection in specified time points.
干预措施: Human derived Transfer factor (Drug)
Control
Aqua pro injectione 4 mL ampules for subcutaneous administration in the same time points as in the active arm
干预措施: Aqua pro injectione 4ml ampules for subcutaneous injection (Drug)
结局指标
主要结局
Composite endpoint that includes the incidence specified infections:
时间窗: 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
次要结局
- The usage of antibiotics required for treatment of a diagnosed infection(Two years)
- Length of hospital stay(Two years)
- The incidence of adverse effects(2 years)
研究者
Martin Janičko
Assistant Professor of Medicine, Faculty of Medicine
Pavol Jozef Safarik University