Pharmacovigilance Evaluation Of Refacto Af (Registered) In Germany And Austria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 101
- 试验地点
- 24
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hemophilia A of any severity already receiving or starting treatment with ReFacto AF.
排除标准
- •Patients with Hemophilia A treated with a product other than Refacto AF.
研究组 & 干预措施
1
Patients treated with Refacto AF
干预措施: ReFacto AF (Moroctocog alfa) (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline until last visit (up to 87 months)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 87 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay
时间窗: Baseline until last visit (up to 87 months)
FVIII inhibitor development was defined as measured inhibitor titer of greater than (\>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline until last visit (up to 87 months)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious adverse events. Relatedness of AEs with Refacto AF was assessed by the investigator.
Mean Total Number of Bleeding Episodes in Participants
时间窗: Baseline until last visit (up to 87 months)
Participants documented all bleeding episodes in a diary during the study.
次要结局
- Investigator Assessment of Treatment Satisfaction of Participants(End of study visit (any time up to 87 months))
- Mean Total Number of Bleeding Episodes Per Year in Participants(Baseline until last visit (up to 87 months))
- Participant Assessment of Satisfaction With Treatment Handling(End of study visit (any time up to 87 months))
- Number of Participants With Change From Baseline Status in Days Missed From School or Work(Baseline until last visit (up to 87 months))