EUCTR2017-000645-48-FI进行中（未招募）1 期
Open-label study to evaluate efficacy and safety of Cystadane for the treatment of aspartylglucosaminuria - Cystadane in the treatment of AG
Minna Laine0 个研究点开始时间: 2017年5月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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 below the age of 15 years who have aspartylglucosaminuria
- •Preferably homozygous for the Finnish major AGU mutation, AGU-Fin-major
- •Written informed consent of the parents
- •No known hypersensitivity or allergy against betain
- •Compliance of the patient
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •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
- •Age above 15 years
- •Patients who do not carry at least one allele of the Finnish major mutation
- •Known adverse reactions against Betain or components of Cystadane
- •Known history of cerebral oedema
- •Participating in other interventional clinical studies
- •Patients who have undergone bone marrow tranplantation
- •Co-medication which would interfere with administration of Betain
研究者
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