2023-510163-35-00招募中3 期
Utility of the use of N-acetylcysteine associated with conventional treatment in patients with severe acute alcoholic hepatitis (Maddrey>=32)
Asociacion Instituto De Investigacion Sanitaria Bioaraba9 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年1月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 9
- 主要终点
- To assess the efficacy of the use of methylprednisolone + NAC, in terms of 1 month mortality, in patients with Severe Acute Alcoholic Hepatitis
研究概览
简要总结
To assess the efficacy of the use of methylprednisolone + NAC, in terms of 1 month mortality, in patients with Severe Alcoholic Hepatitis
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Age from 18 to 75 years.
- •Diagnosed with acute alcoholic hepatitis per AASLD guidelines or compatible liver histology
- •Maddret Score >= 32
- •Willingness to participate expressed through written informed consent
排除标准
- •Alternate cause of jaundice
- •Uncontrolled concomitan diseases (HBV, HCV, HIV, TB, DILI, HCC or acute pancreatitis)
- •Multiple organ failure or shock
- •Allergy or intolerance to NAC and/or corticosteroids
- •Hepatocellular carcinoma
- •Life expectancy under 12 months due to comorbid conditions
- •Current treatment with nitroglycerin and/or carmazepine
- •Uncontrolled active infections
- •Acute renal failure with creatinine > 2,5 mg/dL
- •Uncontrolled upper gastrointestinal bleeding
结局指标
主要结局
To assess the efficacy of the use of methylprednisolone + NAC, in terms of 1 month mortality, in patients with Severe Acute Alcoholic Hepatitis
To assess the efficacy of the use of methylprednisolone + NAC, in terms of 1 month mortality, in patients with Severe Acute Alcoholic Hepatitis
次要结局
- To assess mortality at three months and six months
- To assess liver complications, infections and renal failure
- To assess the tolerance to NAC
- To assess the relationship between the Lille index at day 7 and the response to treatment
研究者
Maria Cabero
Scientific
Asociacion Instituto De Investigacion Sanitaria Bioaraba
研究点 (9)
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