MOdalities of Use, effectiveNEss and TOlerability of Eqwilate® a Balanced combInatiON of VWF and FVIII in Von WillEbrand Patients in Real-life Conditions: the ONE-TO-ONE Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Octapharma
- 入组人数
- 38
- 试验地点
- 9
- 主要终点
- Occurrence of Bleeding Episodes During Follow-Up
研究概览
简要总结
MOdalities of use, effectiveNEss and TOlerability of Eqwilate® a balanced combInatiON of VWF and FVIII in von WillEbrand patients in real-life conditions: the ONE-TO-ONE study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will involve patients (≥ 6 years of age) from the participating centres treated with Eqwilate® (either on-demand, as perioperative prophylaxis, or as prophylaxis) during the time inclusion period will be opened. Patients will be of any VWD type, previously treated or untreated.
排除标准
- 未提供
研究组 & 干预措施
Eqwilate
干预措施: Eqwilate (Biological)
结局指标
主要结局
Occurrence of Bleeding Episodes During Follow-Up
时间窗: 12 months
Occurrence of Bleeding Episodes During Follow-Up
Haemostatic Effectiveness of Perioperative Prophylaxis
时间窗: 12 months
Haemostatic Effectiveness of Perioperative Prophylaxis (excellent, good, moderate, none) none: severe uncontrolled bleeding or intensity of bleeding not changed (in case of non-severe bleeding episodes); moderate: moderate bleeding, or control of bleeding required additional product; good: slight oozing and adequate control of bleeding episode and did not require additional product; excellent: haemostasis achieved, cessation of bleeding episode.
Haemostatic Effectiveness of On-demand Treatment
时间窗: 12 months
Haemostatic Effectiveness of On-demand Treatment (excellent, good, moderate, none) none: severe uncontrolled bleeding or intensity of bleeding not changed (in case of non-severe bleeding episodes); moderate: moderate bleeding, or control of bleeding required additional product; good: slight oozing and adequate control of bleeding episode and did not require additional product; excellent: haemostasis achieved, cessation of bleeding episode.
次要结局
- FVIII Levels(12 months)
- Immunogenicity Presence of inhibitors against VWF(12 months)
- Productivity Loss(12 months)
- Volume of Blood loss(up to 1 week)