ISRCTN25330204已完成不适用
Surveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate®
Octapharma AG (Switzerland)0 个研究点目标入组 24 人开始时间: 2008年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male and female patients of any age
- •2. Suffering from congenital VWD
- •3. In need of replacement therapy with factor concentrate
- •4. Patients starting with a prophylactic treatment must have documentation of at least three apparently spontaneous bleeding episodes (any bleeding site and treated with factor concentrate) in the 6 months prior to enrolment
- •5. Patients switching from a prophylactic treatment with another factor concentrate to prophylaxis with Wilate® should have anamnesis of bleeds with respective documentation in the period of 12 months prior to enrolment
排除标准
- •1. Presence of a bleeding disorder other than VWD
- •2. History of non-compliance
- •3. Difficulties in achieving venous access that would prohibit prophylaxis
- •4. Incapability to follow the requirements of the surveillance, e.g. unable to keep a patient diary
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