EUCTR2008-000795-24-SE进行中（未招募）1 期
Surveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate - WILCOME
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients of any age suffering from congenital VWD in need of replacement therapy with factor concentrate.
- •Patients starting with a prophylactic treatment for the first time must have documentation of at least 3 apparently spontaneous bleeding episodes (any bleeding site and treated with VWF concentrate) in the 6 months prior to enrolment.
- •Patients switching from a prophylactic treatment with another VWF/FVIII concentrate to prophylaxis with Wilate should have anamnesis of bleeds with respective documentation in the period of 12 months prior to enrolment.
- •Written informed consent from patient or patient’s parents.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Presence of a bleeding disorder other than VWD.
- •History of non-compliance.
- •Difficulties in achieving venous access.
- •Incapability to follow the requirements of the surveillance, e.g. unable to keep a patient diary.
研究者
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