EUCTR2014-004693-42-GB进行中（未招募）1 期
A Multicenter, Open Label, Single- and Multiple-Dose, Dose Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
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
- •1. Male or female pediatric subjects, aged <18 years
- •2. Diagnosis of biliary atresia
- •3. Demonstrated successful HPE (also known as Kasai portoenterostomy) as defined by total
- •<2 mg/dL (34.2 µmol/L) at least 3 months post-HPE procedure.
- •4. Able to take medications orally (ie, tablet or mini-tablet formulations)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 72
- •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
- •1. Prior liver transplant or active status on transplant list
- •2. Complications of decompensated cirrhosis including:
- •a. Total bilirubin =2 mg/dL (34.2 µmol/L)
- •b. Platelets <40,000/µL
- •d. Recent (within the previous 6 months prior to Screening) bleeding from gastroesophageal varices
- •e. Recent (within the previous 6 months prior to Screening) uncontrolled ascites (diuretic resistant)
- •f. Hepatic encephalopathy
- •g. Prior placement of portosystemic shunt
- •h. Diagnosis of hepatopulmonary syndrome or portopulmonary hypertension
- •3. Current intractable pruritus or those requiring systemic treatment for pruritus within 3 months of Screening (eg, with bile acid sequestrants or rifampicin)
- •4. Subjects aged <2 years
- •5. Subjects weighing <11 kg.
研究者
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