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临床试验/NCT02049099
NCT02049099已完成不适用

A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care

Swedish Orphan Biovitrum2 个研究点 分布在 2 个国家目标入组 1,658 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,658
试验地点
2
主要终点
Total dose (IU) issued of Factor IX during a 12 month period

研究概览

简要总结

To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.

详细描述

The study population consists of patients with a diagnosis of ICD10: haemophilia A D66.9 or haemophilia B D67.9.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients with severe or moderate haemophilia A or haemophilia B.
  • Treatment with Factor VIII/Factor IX products initiated at least 24 months before inclusion in the study.
  • Informed consent is obtained from the patient or patient's legal representative (as applicable according to legal regulation).

排除标准

  • Confirmed positive inhibitor test detected in the past 24 months.

结局指标

主要结局

Total dose (IU) issued of Factor IX during a 12 month period

时间窗: - 12 month to Day 0

Total dose (IU) issued of Factor VIII during a 12 month period

时间窗: - 12 month to Day 0

次要结局

未报告次要终点

研究者

发起方
Swedish Orphan Biovitrum
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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