临床试验/NCT01285089

NCT01285089已完成不适用

Prospective French Study on ACQUIred Haemophilia Treatment With Recombinant Factor VIIa (NovoSeven®) A Prospective Observational Study on the Use of NovoSeven® (Activated Recombinant Human Factor VIIa) for the Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia

Novo Nordisk A/S0 个研究点目标入组 21 人开始时间: 2010年12月最近更新: 2014年1月30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: Novo Nordisk A/S
入组人数: 21
主要终点: Identification of decision criteria to treat patient with activated recombinant human factor VII

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记录与标识符相似试验

研究概览

简要总结

This study is conducted in Europe. The aim of this prospective, observational study are to describe the different clinical practice and detailed haemostatic management of activated recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France. The secondary aim is to assess the primary haemostasis disorder associated with the coagulation disorders, if available.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Diagnosed with acquired haemophilia
•Treated with activated recombinant human factor VII as first line treatment
•Treated with activated recombinant human factor VII after January 2011

排除标准

•Patients with first diagnosis before january 2010 and having a relapse after january 2011
•Known hypersensitivity to NovoSeven®, or to mouse, hamster or bovine protein

研究组 & 干预措施

A

干预措施: activated recombinant human factor VII (Drug)

结局指标

主要结局

Identification of decision criteria to treat patient with activated recombinant human factor VII

时间窗: Year 3

次要结局

Number of patients with a control of bleeding(Year 3)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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