IRCT20150303021315N30已完成3 期
A phase III, single-arm, cross-over, multicenter clinical trial to compare efficacy and safety of YW17 (laronidase; CinnaGen) versus laronidase (Aldurazyme®; Genzyme, BioMarin) in patients with Mucopolysaccharidosis type I (MPS I)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 5 years 至 18 years（—）
- 性别
- All
入选标准
- •Patients Aged Between 5 to 18 years
- •Mucopolysaccharidosis type I confirmed
- •Willingness and having informed consent (patient or his/her parents/ legal guardian) to participate in this study
排除标准
- •Prior bone marrow transplantation
- •Being a candidate for receiving hematopoietic stem cell transplantation
- •Prior Tracheotomy
- •Administration of any investigational drug within 30 days before study enrollment
- •Medical condition or other circumstance that could significantly interfere with study compliance
- •The severe organic disease that is not associated with mucopolysaccharidosis type 1
- •Known hypersensitivity to laronidase or components of the laronidase solution
- •Abnormal renal function determined by measuring serum creatinine and blood urea nitrogen (BUN) levels
- •Acute hydrocephalus
- •Prescribing laronidase for the first time for the patient (naive patient)
研究者
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