EUCTR2011-004528-36-Outside-EU/EEA进行中（未招募）不适用
An open-label, single center, non-randomized, continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •Patients completing protocol CAC-001-01 or transitioned from protocol 91-10-10 or children with newly diagnosed inborn errors of bile acid synthesis.
- •Any new, additional infants, children, and adolescents presenting for evaluation of cholestasis defined as a conjugated bilirubin > 2mg/dl or evaluation chronic liver disease, fat and fat soluble vitamin deficiency, growth failure or other signs or symptoms consistent with intestinal intraluminal bile acid deficiency. Patients will have undergone thorough evaluation to define the etiology of cholestasis using conventional screening studies (urine culture a-1-antitrypsin pheno¬type, endocrine studies, STORCH titers, thyroid function tests, liver ultrasound, liver function tests and percutaneous liver biopsy).
- •Older patients of any age with chronic liver disease if urine screens indicate that they have inborn errors of bile acid metabolism.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- 未提供
研究者
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