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临床试验/EUCTR2014-000102-35-IT
EUCTR2014-000102-35-IT进行中(未招募)1 期

Effect of administration add on of Rifaximin on portal hypertension of patients with liver cirrhosis and esophageal varices in standard therapy with propranolol - ERASE study

Clinica Medica 50 个研究点目标入组 60 人开始时间: 2014年10月24日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1) Diagnosis of liver cirrhosis (based on clinical, biochemical and radiological criteria with or without liver biopsy)
  • 2) Presence of esophageal varices at high risk of bleeding
  • 3) HVPG> 12 mmHg.
  • 4) previous treatment with non-selective beta blockers
  • 5) 19=age=75
  • 6) Informed Consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 50
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • 1) Patients already treat with beta blockers and then in the secondary prophylaxis for rebleeding
  • 2) Treatment with systemic antibiotics and / or non-absorbable intestinal antibiotics in the previous two weeks
  • 3) Bacterial infection, spontaneous bacterial peritonitis
  • 4) overt hepatic encephalopathy in the last week
  • 5) Gastrointestinal bleeding in act, or in the lastweek
  • 6) active alcoholism or drug abuse in last 3 weeks
  • 7) Acute Alcoholic Hepatitis
  • 8) Hepatocellular carcinoma or other neoplasm
  • 9) significant coronary artery disease (angina NYHA III / IV), congestive heart failure (NYHA III / IV), relevant cardiomyopathy, history of myocardial infarction within the last 12 months
  • 10) Contraindications to the administration of beta blockers; allergy to Rifaximin
  • 11) Pregnancy or lactation
  • 12) Refusal to participate

研究者

发起方
Clinica Medica 5

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