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临床试验/IRCT20200427047225N1
IRCT20200427047225N1已完成3 期

The effect of Fenofibrate on the Clinical Outcome of primary Sclerosing Cholangitis

Shahid Beheshti University of Medical Sciences0 个研究点目标入组 30 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 75 years(—)
性别
All

入选标准

  • chronic cholestatic liver disease for atleast 6 month
  • alkaline phosphatase serum level atleast 1.5x upper limit normal
  • multi focal dilation and stricture in intra/extra hepatic billiary ducts on MRCP or liver biopsy confirmed PSC (fibrosing cholangitis, ductopenia, peei portal inflammation or biliary fibrosis)

排除标准

  • concurrent advanced malignancy or severe cardiopulmonary disease with less than 2 years survival
  • inlammatory intestinal diseasethat need medical therapy during 3 month from begining (except miantenance therapy with 5-ASA)
  • candidate for liver transplant and survival less than 80% in 2 years according to MAYO risk score
  • portal hypertension complicatin such as variceal bleeding ascitis liver encephalopathy
  • pregnancy or breast feeding
  • age under 18 years or above 75 years
  • other liver disease diagonosis sucg as chronic alcoholic livera disease, B or C hepatitis, auto immune hepatitis, primary biliary cirrosis, hemochromatosis, wilson disease, congenital biliary disease or cholangiocarcinoma
  • previous biliary stone or ductal manipulation, cholecycstectomy or other biliary drainage before PSC confirmed
  • ascending biliary cholangitis need more than twice a years admission
  • patient who di not allow
  • fenofibrate allergy or intolerance or side effects
  • concurrent use of local or systemic anti-itch agents such as anti histamins

研究者

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