jRCT2041250146进行中（未招募）不适用
Post-Trial Access (PTA) Program for Patients in Japan with Metachromatic Leukodystrophy who Received SHP611 While Participating either in the SHP611-201 or the HGT-MLD-071 Study
未提供0 个研究点目标入组 4 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Other
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- No limit 至 No limit（—）
- 性别
- All
入选标准
- •The patient must be a resident of Japan and must be receiving SHP611 through either the SHP611-201 or the HGT-MLD-071 study.
- •The patient must derive continued benefit from SHP611 treatment in the opinion of their parent(s) or legally authorized representative(s) in consultation with their treating physician.
- •The patient must have no safety or medical issues that, in the opinion of the treating physician, would contraindicate participation.
- •The patient's parent(s) or legally authorized representative(s) must provide consent through the Information Sheet for participation in the program.
排除标准
- •Any patients with metachromatic leukodystrophy (MLD) not enrolled in either parent studies (SHP611-201 or the HGT-MLD-071) will not be eligible for participation in this program.
研究者
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