EUCTR2008-000084-41-FR进行中（未招募）1 期
A multi-center open label extension study of HGT-1111 (Recombinant Human Arylsulfatase A or rhASA) treatment in patients with Late Infantile Metachromatic Leukodystrophy (MLD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 11
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
- •1. The patient's legally authorized guardian(s) must provide signed informed consent prior to the performance of any study-related activities. (Study-related activities are any procedures that would not have been performed during normal management of the subject).
- •2. Completion of study HGT-MLD-048
- •3. The patient and his/her guardian(s) must have the ability to comply with the clinical protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •1. Spasticity so severe that it inhibiits the patient from being transported to the treatment site.
- •2. Presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or any other medical condition that, in the opinion of the investigator, would preclude participatioin in the trial.
- •3. Any other medical condition or serious intercurrent illness or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial.
研究者
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