NCT01918462已完成不适用
Protective Immune Mechanisms in Alcoholic Hepatitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Frequency of IL-22-producing cells
研究概览
简要总结
The purpose of this study is to investigate the production, effects and interactions of the hepato-protective cytokine interleukine (IL)-22 in patients with alcoholic hepatitis.
详细描述
The investigators will study hepatic biopsies from patients with alcoholic hepatitis. In these biopsies, the investigators will assess the production of IL-22 and which cells produce the cytokine. The investigators will study the expression of the IL-22 receptor and also the production of the IL-22 binding protein, which can inhibit the actions of the cytokine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of alcoholic hepatitis:
- •relevant history of alcohol consumption (>40g/day for a minimum of 6 months with cessation of consumption no earlier than 3 months prior to admission)
- •bilirubin > 80 mol/l
- •neutrophil granulocytes > 10x10^9/L
- •exclusion of other liver pathology including biliary disease
- •histological verification on liver biopsy
- •Written, informed consent
排除标准
- •Other chronic inflammatory or autoimmune diseases
- •Severe, acute bacterial infection (peritonitis, sepsis, pneumonia, urinary tract infection etc.)
- •Prednisolon or pentoxifylline treatment within the past 8 weeks
- •Pregnancy
结局指标
主要结局
Frequency of IL-22-producing cells
时间窗: at day 1 ( the day of diagnosis/arrival to the department)
This will be detected in hepatic biopsies taken at inclusion to the study.
次要结局
- IL-22 binding protein(at day 1 ( the day of diagnosis/arrival to the department))
- IL-22 receptor(at day 1 ( the day of diagnosis/arrival to the department))
- Signalling molecules and markers of hepatocyte destruction(at day 1, at day 7 and at day 90 after diagnosis.)
研究者
研究点 (1)
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