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临床试验/NCT04247906
NCT04247906Approved For Marketing不适用

Single Patient Expanded Access Treatment Plan (EAP; Also Known As A Compassionate Use Plan) To Provide Patients Access To The Investigational Product Narsoplimab

Omeros Corporation0 个研究点开始时间: 2020年1月30日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
Approved For Marketing

研究概览

简要总结

The purpose of the EAP is to provide access to hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) patients who may benefit from treatment with narsoplimab based on the medical judgement of their respective physicians.

研究设计

研究类型
Expanded Access

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient (adult or pediatric) must have undergone allogeneic or autologous hematopoietic stem cell transplant (HSCT)
  • Patient must be capable of understanding an informed consent form (ICF) or the parent or legal guardian of the patient is able to understand and sign a written ICF prior to the initiation of any treatment procedures.
  • Patient must have HSCT- TMA defined as having thrombocytopenia and evidence of microangiopathic hemolytic anemia.

排除标准

  • 未提供

研究者

申办方类型
Industry
责任方
Sponsor

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