NCT02263066已完成不适用
Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 181
- 主要终点
- Duration of regular prophylaxis
研究概览
简要总结
To assess and describe real-life treatment choices for rFⅧ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, 2-<18 years Hemophilia A, based on documented prior testing and/or screening laboratory Patients who had received regular prophylaxis/bleeding prevention treatment, totally/partially with rFⅧ. Regular prophylaxis/bleeding prevention treatment is defined as that proportion of weeks (≥2 infusion/week) of total treatment weeks≥80%[10] , and total duration ≥12 weeks. During the regular prophylaxis period, if there were consecutive 4 weeks that <2 infusion/week, the beginning day of the 4 weeks is defined as the end of regular prophylaxis.
- •Available patient medical data record Written informed consent by parent/legal representative. Consent should be sought from subjects if appropriate
排除标准
- •Patients with measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation (≥0.6BU by Bethesda assay at two different time points, documentation must be available) Any individuals with another bleeding disease that is different from hemophilia A (e.g, von Willebrand disease, hemophilia B)
结局指标
主要结局
Duration of regular prophylaxis
时间窗: Up to 1.5 years
Percentage of rFVIII usage in prophylaxis
时间窗: Up to 1.5 years
Prophylaxis infusion dose
时间窗: Up to 1.5 years
次要结局
- Quality of life by questionnaire(Up to 1.5 years)
- Bleeding frequency(Up to 1.5 years)
- Joint physical examination score(Up to 1.5 years)
- Joint radiographic score(Up to 1.5 years)
研究者
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