EUCTR2019-001015-23-FR进行中（未招募）1 期
Double blind, multicentric, randomized, placebo-controlled trial, evaluating the efficacy of 24-month of bezafibrate in primary sclerosing cholangitis with persistent cholestasis despite ursodeoxycholic acid therapy - BEZASCLER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 104
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
- •Males or females = 18 and = 75 years
- •Large duct PSC verified by retrograde, operative, percutaneous or
- •magnetic resonance cholangiography (MRC) demonstrating intrahepatic
- •and /or extrahepatic biliary duct changes consistent with PSC
- •Colonoscopy within the last 5 years (or within 3 months if IBD is
- •associated to PSC) with no cancer nor all-grade dysplasia
- •ALP = 1.5 ULN at baseline
- •Treatment with UDCA (15-20 mg/kg/d) for = 6 months before
- •contraceptive in women of childbearing potential. Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e., less than 1% per year) when used constantly and correctly.
- •Affiliation to a social security system (AME excepted)
- •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 52
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 52
排除标准
- •Child-Pugh score B or C
- •Ascites or digestive hemorrhage (or history of)
- •Total bilirubin in the last 3 months > 50 µmole/L (3 mg/dl)
- •Gilbert syndrome defined as unconjugated bilirubinemia > 12 µmol/L
- •Albumin in the last 3 months < 35 g/L
- •Prothrombin index in the last 3 months < 70%
- •Platelets count in the last 3 months < 100000/mm3
- •ALT or AST > 5 ULN in the last 3 months
- •Prior liver transplantation
- •Treatment with a fibrate within the last 3 months inclusion or with a
- •statin at inclusion
研究者
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