EUCTR2015-002805-13-FR进行中（未招募）1 期
ongterm Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
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
- Male
入选标准
- •1. Provision of written informed consent for this study by the subject or subject’s parent(s)/ legal guardian(s) and written informed assent by subject, if applicable
- •2. Have received Lenti-D Drug Product in Study ALD-102
- •3. Able to comply with study requirements
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Met the VCN discontinuation criterion from Study ALD-102, as follows:
- •the subject has undetectable VCN (<0.0003 copies per cell) in peripheral blood cells for 2 consecutive measurements at least 1 month apart and at least 12 months after drug product infusion.
- •This exclusion criterion does not apply to subjects who received allo-HSCT after Lenti-D Drug Product infusion in Study ALD-102
研究者
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