EUCTR2015-001157-32-DK进行中（未招募）1 期
An exploratory Phase II Study to demonstrate the Safety and Efficacy of A4250 in Children with Cholestatic Pruritus
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Albireo AB
- 入组人数
- 24
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
- •Diagnosis of pruritus due to chronic cholestasis based on history and investigator judgment
- •- This will include but will not be restricted to patients with Progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS), Biliary Atresia and Sclerosing Cholangitis
- •Laboratory markers of cholestasis identified within 3 months before Visit 1
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any condition that in the opinion of the investigator constitutes a risk for the patient or a contraindication for participation and completion of the study, or could interfere with study objectives, conduct, or evaluations
- •Clinical or biochemical signs of decompensated liver disease
- •Liver transplantation
- •Other reason for pruritus than chronic cholestasis such as treatment refractory atopic dermatitis, other primary skin diseases etc.
- •Treatment with bile acid sequestrants (cholestyramine, colesevelam, colestipol or similar) during the screening period
研究者
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