NCT07579910尚未招募3 期
A Phase 3, Randomized, Single-blind, Parallel Group, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Intracerebroventricular Tralesinidase Alfa Treatment Compared to Standard of Care in Mucopolysaccharidosis Type IIIB (MPS IIIB, Sanfilippo Syndrome Type B)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 14
研究概览
简要总结
The primary objectives of this study are to evaluate the effects of Tralesinidase Alfa (TA) on cognition
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis of MPS IIIB confirmed by deficient NAGLU enzyme activity during screening.
- •Has nonattenuated severe MPS IIIB by the Genotype and Clinical Assessment Committee.
- •Is ≥1 and ≤5 years of age with BSID-III-C raw score of <
- •Is male or female as identified at birth.
排除标准
- •Genotyped for a known MPS IIIB variant associated with an attenuated phenotype or has a sibling with a known attenuated phenotype.
- •Has another neurological illness that may have caused cognitive decline (e.g., trauma, meningitis, or hemorrhage) before study entry.
- •Has received stem cell, gene therapy, or enzyme replacement therapy for MPS IIIB.
研究组 & 干预措施
Tralesinidase alfa (TA)
Experimental
干预措施: Tralesinidase alfa (TA) (Drug)
Control
No Intervention
研究者
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