Efficacy of NovoSeven® (Activated Recombinant Human Factor VII): Non-interventional Study in Patients With Congenital Haemophilia With Inhibitors, Acquired Haemophilia, Factor FVII Deficiency, and Glanzmann's Thrombasthenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved
研究概览
简要总结
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from patient or patient's legally acceptable representative in which he agrees that the patient's pseudonymised personal data will be transferred for use in a scientific evaluation and publication
排除标准
- •Due to the non-interventional observational character of the study, there are no exclusion criteria.
研究组 & 干预措施
A
干预措施: eptacog alfa (activated) (Drug)
结局指标
主要结局
Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved
时间窗: within 9 hours after initiation of treatment with NovoSeven® or of invasive procedures for which haemostasis will be maintained during the time period of haemostatic coverage with NovoSeven®
次要结局
- Proportion of patients experiencing one or more re-bleeds(within 24 hours after begin of an acute bleeding episode that was successfully treated with NovoSeven® (stop or significant reduction of bleeding))
- Time proportion of acute bleeding treatments resulting in effective pain relief(within 9 hours after initiation of treatment with NovoSeven®)