EUCTR2011-004491-10-Outside-EU/EEA进行中（未招募）不适用
An Open-Label, Single-Center, Nonrandomized Study to Compare the Therapeutic Efficacy of To Be Marketed (TBM) Cholic Acid Capsules with that of the Currently Used (CU) Formulation of Cholic Acid Capsules Used to Treat Children 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
- 16
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
- •The patient must have stable transaminase levels within 2 times the upper limits of the normal range.
- •The patient must have a diagnosis of an inborn error of bile acid synthesis.
- •The patient and/or parent/legal guardian must have signed the written informed consent document before study start.
- •Assent must be obtained from eligible children greater than age 7 years
- •The patient must be currently receiving CU cholic acid therapy under IND 45,470.
- •The patient must be willing and able to comply with all study assessments and procedures.
- •The patient must be able to make two visits (Visit 1 and Visit 2) to the study site (CCHMC).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 16
- •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
排除标准
- 未提供
研究者
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