NCT01142323终止1 期
Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Serum Alkaline Phosphatase
研究概览
简要总结
The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients of 18 to 75 years old
- •Confirmed diagnosis of PSC including typical findings of stricturing and dilatations of the intra and/or extrahepatic biliary ducts in radiographic exam, (endoscopic retrograde cholangiopancreatography -ERCP, percutaneous cholangiogram - PTC or magnetic resonance cholangiopancreatography- MRCP)
- •Serum alkaline phosphatase levels elevated to at least 1.5 times the upper limit of normal.
排除标准
- •Hypersensitivity to fenofibrate
- •Prisoners and institutionalized subjects
- •Pregnant or nursing women
- •Anticipated need for liver transplantation in one year
- •Recipients of liver transplantation
- •Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
- •Co-existing liver diseases including auto-immune and viral hepatitis
- •Acute or chronic renal failure, defined as glomerular filtration rate (GFR)< 60 ml/min, GFR calculated using the Modification of Diet in Renal Disease (MDRF) GFR calculator
- •Known cholecystitis
- •Current use of statins
- •Current use of coumadin anticoagulant therapy
- •Previous history of, or known high risk for, venous thromboembolism,
研究组 & 干预措施
Fenofibrate
Experimental
fenofibrate 160 mg po daily
干预措施: fenofibrate (Drug)
结局指标
主要结局
Serum Alkaline Phosphatase
时间窗: 6 months
Serum alkaline phosphatase will be measured at entry and end of study
次要结局
- Mayo Risk Score for Primary Sclerosing Cholangitis(6 months)
研究者
Cynthia Levy
Associate Professor of Clinical
University of Miami
研究点 (2)
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