NCT01949220已完成不适用
International Post-Marketing Surveillance of Willfact-Wilfactin in Patients With Inherited Von Willebrand Disease.
Laboratoire français de Fractionnement et de Biotechnologies17 个研究点 分布在 7 个国家目标入组 80 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
- 80
- 试验地点
- 17
- 主要终点
- Documentation of product consumption data
研究概览
简要总结
Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify the therapeutic practices in an international environment.
详细描述
Non-interventional, prospective, non comparative, international, multicentre study.
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 inherited von Willebrand disease
- •Patients treated with WILLFACT or WILFACTIN
- •Patient or parent/legal representative who has provided written signed and dated informed consent before any data collection.
排除标准
- •Patients who usually do not keep injection log up to date, when treated.
结局指标
主要结局
Documentation of product consumption data
时间窗: at each follow-up visit, up to 24 months
Product consumption (VWF International Units) by analysis of posology, frequency in relation to the severity of bleeding, type of surgery and other clinical situations.
次要结局
- Collection and analysis of adverse events and VWF immunological safety(at each follow-up visit, up to 24 months)
研究者
研究点 (17)
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