Pharmacovigilance Evaluation Of Refacto In Usual Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Mean Number of Bleeding Episodes Per Patient Year
研究概览
简要总结
The purpose of this study is to investigate the effectiveness and safety of treatment with ReFacto under conditions of routine therapy. Furthermore a continuous benefit/risk assessment will be done.
详细描述
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Proven diagnosis of Hemophilia A
排除标准
- •Contraindications according to Summary of Product Characteristics
研究组 & 干预措施
A
Patients with Hemophilia A
干预措施: Moroctocog alfa (Drug)
结局指标
主要结局
Mean Number of Bleeding Episodes Per Patient Year
时间窗: Baseline up to a mean duration of 54 months
Participants with hemophilia A suffer from a hereditary lack of blood clotting factor VIII. As a consequence, the ability of the blood to coagulate is reduced and bleedings at any site or organ of the body may occur after minor injury or even spontaneously. Predominantly, joints, muscles, and internal organs are affected by bleeding complications. Participants reported the occurrence of each bleeding episode while on study. The bleeding rate for each participant was calculated by number of reported episodes per years on study.
Mean Number of Bleeding-related Exposure Days Per Patient Year
时间窗: Baseline up to a mean duration of 54 months
Exposure days are the number of days of treatment with ReFacto.
Mean Number of Exposure Days Per Patient Year
时间窗: Baseline up to a mean duration of 54 months
Exposure days are the number of days of treatment with ReFacto.
次要结局
- Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to a mean duration of 54 months)
- Number of Participants With de Novo Inhibitor Formation(Baseline up to a mean duration of 54 months)
- Mean Annual ReFacto Consumption Per Patient Year(Baseline up to a mean duration of 54 months)
- Number of Participants for Physicians' Assessment of Satisfaction With Treatment Success(Baseline up to a mean duration of 54 months)
- Number of Participants for Physicians' Assessment of Efficacy(Baseline up to a mean duration of 54 months)
- Number of Participants for Patients' Assessment of Efficacy(Baseline up to a mean duration of 54 months)
- Number of Participants for Physicians' Assessment of Tolerance(Baseline up to a mean duration of 54 months)
- Number of Participants for Patients' Assessment of Tolerance(Baseline up to a mean duration of 54 months)
- Number of Participants for Physicians' Assessment of Handling of ReFacto(Baseline up to a mean duration of 54 months)
- Number of Participants for Patients' Assessment of Handling of ReFacto(Baseline up to a mean duration of 54 months)
- Number of Participants for Days of Sick Leave Per Month(Baseline up to a mean duration of 54 months)