NL-OMON21663已完成不适用
Efficacy and safety of enzyme replacement therapy for MPS I with 100 I.U./Kg recombinant human a-L-iduronidase (ALDURAZYME™).
CVZ0 个研究点目标入组 35 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. The patient must give written informed consent;
- •2. If the patients is younger than 12 years, informed consent from his/her parents or his/her legal representative is necessary;
排除标准
- •1. Patient is unable or unwilling to comply with the study protocol;
- •2. Parent(s) or legal representatives are unable or unwilling to comply with the evaluation program;
研究者
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已完成
不适用
Efficacy and safety of enzyme replacement therapy for Mucopolysaccharidosis type I with 100 IU/Kg recombinant human a-L-iduronidase (Aldurazyme™)Mucopolysaccharidosis type INutritional, Metabolic, EndocrineDisorders of metabolismISRCTN22324060Erasmus Medical Centre (The Netherlands)35
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atural course, effects of enzyme therapy and health economic aspects in patients with mucopolysaccharidosis type I, II and VI. Long-term folloe-up of untreated patients and patients receiving commercially available Aldurazyme, Elaprase and Naglazyme.Hunter syndrome and Maroteaux-Lamy syndrome)lysosomal storage disorders (Hurler syndrome100274241002160510028396NL-OMON35691Erasmus MC, Universitair Medisch Centrum Rotterdam50
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不适用
atural course, effects of enzyme therapy and health economic aspects in patients with mucopolysaccharidosis type I, II and VI. Long-term folloe-up of untreated patients and patients receiving commercially available Aldurazyme, Elaprase and Naglazyme.Mucopolysaccharidosis type I, II and VI.MedDRA version: 12.0Level: LLTClassification code 10028095Term: Mucopolysaccharidosis IVMedDRA version: 12.0Level: LLTClassification code 10056886Term: Mucopolysaccharidosis IMedDRA version: 12.0Level: PTClassification code 10056889Term: Mucopolysaccharidosis IIEUCTR2007-001453-26-NL50