临床试验/NCT04106895

NCT04106895已完成不适用

Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data

Octapharma5 个研究点分布在 1 个国家目标入组 200 人开始时间: 2019年2月21日最近更新: 2021年5月13日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Octapharma
入组人数: 200
试验地点: 5
主要终点: proportion of treatments given for an ongoing bleeding episodes

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To describe the characteristics of patients treated with Fibryga®, the indications and conditions of use of Fibryga® and, for patients treated " on-demand", the short-term outcomes.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Retrospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Patient with fibrinogen deficiency (congenital or acquired)
•Having received an treatment with Fibryga® during the recollection period
•Having been informed of the potential retrospective collection of their data by a Clinical Research Associate mandated by Octapharma® when Fibryga® has been delivered and who did not refuse.

排除标准

未提供

研究组 & 干预措施

Fibryga

干预措施: Fibryga (Drug)

结局指标

主要结局

proportion of treatments given for an ongoing bleeding episodes

时间窗: 6 months

Estimate the proportion of treatments given for an ongoing bleeding episodes (opposed to preventative treatment administered for example before surgery or to regular prophylaxis)

次要结局

Surgical Prophylaxis Success(6 months)
On-demand Treatment Success(6 months)

研究者

发起方

Octapharma

申办方类型

Industry

责任方

Sponsor

研究点 (5)

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