NCT02485106Unknown3 期
Effect of Gut Decontamination Using Rifaximin in the Patients With Severe Alcoholic Hepatitis
Saint Vincent's Hospital, Korea0 个研究点目标入组 170 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 170
- 主要终点
- Mortality
研究概览
简要总结
This study aimed to investigate the effect of decontamination by rifaximin in severe alcoholic hepatitis patients. Patients who take corticosteroid or pentoxifylline will be randomly allocated to rifaximin group or control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heavy alcohol drinking within 3 months (Over 40 g/day)
- •Maddrey's discriminant function ≥ 32
- •AST/ALT ration ≥ 2
- •Bilirubin level ≥ 5mg/dL
- •Any one of the following additional criteria : hepatic encephalopathy, enlarged, tender liver, or peripheral leucocytosis
- •Age : 19-75
- •Jaundice within 3 months
排除标准
- •Other causes of chronic liver disease (HBV, HCV, or autoimmune hepatitis)
- •Antibiotics or probiotics use within 8 weeks
- •Drug induced hepatotoxicity
- •Acute viral hepatitis (HAV or HEV)
- •Hepatic abscess or cholagitis
- •Hepatocellular carcinoma of modified UICC stage II, III or IV
- •Malignant tumor other than HCC
- •Pregnancy
- •Severe chronic extrahepatic disease
- •Type I hepatorenal syndrome
- •Hepatic encephalopathy grade II or IV
- •Severe infection
研究组 & 干预措施
Rifaximin group
Active Comparator
Corticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days
干预措施: Rifaximin (Drug)
Rifaximin group
Active Comparator
Corticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days
干预措施: Corticosteroid or pentoxifylline (Drug)
Control group
Active Comparator
Corticosteroid or Pentoxifylline for 28 days
干预措施: Corticosteroid or pentoxifylline (Drug)
结局指标
主要结局
Mortality
时间窗: 6-month
次要结局
未报告次要终点
研究者
Do Seon Song
Clinical assistant professor
Saint Vincent's Hospital, Korea
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