EUCTR2011-004681-15-AT进行中（未招募）不适用
Effects of the activation of peroxisome proliferator-activated receptors in patients with primary biliary cirrhosis - Effects of the activation of PPARs in patients with PBC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Incomplete responders to standard UDCA therapy (AP > 1.5x ULN after one year)
- •PBC stage I – II (biopsy proven and/or positive AMA)
- •Male or female gender
- •Age 18 – 70 years
- •Normal kidney function
- •Signed 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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •PBC stage III – IV
- •Age > 70 years
- •Decompensated liver disease (Child-Pugh class B/C, presence of ascites, esophageal varices)
- •Cholelithiasis
- •ALT or AST > 3x ULN
- •CK > 5x ULN or CK >3x ULN with muscle pain, tenderness or weakness
- •Pregnancy or breastfeeding
- •Premenopausal women without certain contraception
- •Known hypersensitivity to fibrates
- •Current treatment with lipid-lowering drugs, immunosuppressants, coumarin-based anticoagulants, monoamine oxidase inhibitors
研究者
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