EUCTR2008-000084-41-IT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) - ND
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 diseas 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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