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临床试验/NCT03720626
NCT03720626Available不适用

Managed Access Programs for SEG101, Crizanlizumab

Novartis Pharmaceuticals0 个研究点开始时间: 2018年10月25日最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

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