Special Drug Investigation of Kovaltry in Hemophilia A Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as measure of safety and tolerability
研究概览
简要总结
The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.
详细描述
This company-sponsored study is a single-arm, prospective, observational study in hemophilia A patients administered Kovaltry. 200 cases will be planned to be registered as safety analysis set in three-year period. Within 200 cases, 50 cases less than 12 years old will be planned to be registered. Target population are all hemophilia A patients. The treatment should be performed based on the product label in Japan. The standard observation period is two years.
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
- •Male and female hemophilia A patients.
- •Patients for whom the decision to treat with Kovaltry was determined prior to enrollment in the study.
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice.
- •Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A
研究组 & 干预措施
BAY81-8973
Hemophilia A patients who require Factor VIII replacement therapy
干预措施: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973) (Drug)
结局指标
主要结局
Number of participants with adverse events as measure of safety and tolerability
时间窗: Up to 2 years
Number of participants with serious adverse events as measure of safety and tolerability
时间窗: Up to 2 years
次要结局
- Number of annual bleeds(Up to 2 years)
- Efficacy of controlling of bleeds(Up to 2 years)