NCT05795361Available不适用
Post-trial Access Program: Idursulfase-IT (HGT-2310) in Conjunction With Intravenous Elaprase® in Pediatric and Adult Patients With Hunter Syndrome and Cognitive Impairment
Takeda37 个研究点 分布在 5 个国家开始时间: 2023年4月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
- 发起方
- 试验地点
- 37
研究概览
简要总结
As the HGT-HIT-046 (NCT01506141) and SHP609-302 (NCT02412787) studies are completed and closed, this post-trial access (PTA) program provides TAK-609 to participants in these studies for whom the benefit:risk ratio of continued treatment with idursulfase-IT remains positive.
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants will have completed the treatment period of the HGT-HIT-046 (NCT01506141) or SHP609-302 (NCT02412787) study prior to the first dose on this program.
- •Participant and/or a parent(s)/legal guardian is informed of the nature of this compassionate post-trial access program and can provide written informed consent for themselves or the child to participate (with assent from the child when appropriate prior to treatment).
排除标准
- •Participant has a condition that in the opinion of the treating physician may compromise their safety.
- •Participant has a known hypersensitivity to idursulfase-IT or its components.
研究者
研究点 (37)
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