临床试验/NCT01579968

NCT01579968已完成不适用

Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 86 人开始时间: 1999年3月10日最近更新: 2017年2月24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: 86
试验地点: 1
主要终点: Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed

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

This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) when undergoing surgery under normal clinical practice conditions.

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

•Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment when undergoing surgery

排除标准

•Patients who was not deemed to be appropriate to the treatment of eptacog alpha (NovoSeven®)

研究组 & 干预措施

eptacog alpha users

干预措施: eptacog alfa (activated) (Drug)

结局指标

主要结局

Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed

时间窗: Year 10

次要结局

Number of adverse events (AEs), including serious adverse events (SAEs)(Year 1, Year 10)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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