Investigation in the Pathogenesis of Liver Disease in Patients with Inborn Errors of bile Acid Metabolism

Asklepion Pharmaceuticals, LLC0 个研究点目标入组 82 人开始时间: 2011年10月6日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Infants < age 3 months
•Children presenting for evaluation of cholestasis defined as a conjugated bilirubin > 2mg/dl or increased serum bile acids
•Older subjects of any age with cholestatic liver disease if urine screens suggested that they had inborn errors of bile acid metabolism
•Confirmation of a diagnosis of an inborn error of bile acid synthesis based upon urine analysis by FAB-MS to determine whether specific abnormalities in bile acid synthesis are indicated
•The patient and/or parent/legal guardian must have signed the written informed consent document before study start.
•The patient must be willing and able to comply with all study assessments and procedures.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 82
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients with other organ dysfunction were not excluded (if Inclusion criteria were otherwise met)

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