NCT03720626Available不适用
Managed Access Programs for SEG101, Crizanlizumab
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
研究概览
简要总结
The purpose of this registration is to list Managed Access Programs (MAPs) related to SEG101, Crizanlizumab
详细描述
CSEG101A2001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CSEG101A2001M to provide access to Crizanlizumab for sickle cell disease patients with history of vaso-occlusive crisis
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 12 Years 至 70 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
- •The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
- •There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
- •The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
- •Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
- •Managed Access provision is allowed per local laws/regulations.
排除标准
- 未提供
研究者
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