IRCT20200427047225N1已完成3 期
The effect of Fenofibrate on the Clinical Outcome of primary Sclerosing Cholangitis
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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