Post Marketing Observational Study Of Reformulated BeneFIX
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment
研究概览
简要总结
The primary objective of this observational study is to collect safety data on reformulated BeneFIX as prescribed in routine clinical practice conditions in France. The secondary objectives are to collect data on the clinical course of individuals treated with reformulated BeneFIX and on the ease of reformulated BeneFIX.
详细描述
No sampling
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
- •Subjects with Hemophilia B already receiving or starting treatment with reformulated BeneFIX.
- •Subjects who have dated and signed the informed consent form.
排除标准
- •Ongoing treatment of Hemophilia B by a product other than reformulated BeneFIX.
- •Participation in the European prospective registry of patients with Hemophilia B treated with BeneFIX (Wyeth protocol 3090A-101039).
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment
时间窗: Baseline up to Year 3.5
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An 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; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred prior to safety amendment. Prior to safety amendment, only AEs/SAEs deemed related to BeneFIX as per participating physician were collected.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment
时间窗: Year 3.5 up to 4.75
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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; congenital anomaly. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug as per participating physician. AEs included SAEs as well as non-serious AEs which occurred after the safety amendment. After the safety amendment, all AEs/SAEs were collected irrespective of their relationship to BeneFIX.
Number of Participants With Events of Special Interest
时间窗: Baseline up to Year 4.75
Events of special interest included allergic reactions, red blood cell (RBC) agglutination phenomena, lack of efficacy/low recovery, thrombotic events and onset of factor IX (FIX) inhibitor. Participants may be represented in more than 1 category.
次要结局
- Number of Bleeding Episodes(Baseline up to Year 4.75)
- Number of Bleeding Episodes Requiring Treatment by Injection(Baseline up to Year 4.75)
- Total Consumption of BeneFIX(Baseline up to Year 4.75)
- Subjective Assessment of Efficacy by Participant(Baseline up to Year 4.75)
- Dose Per Injection of BeneFIX(Baseline up to Year 4.75)
- Subjective Assessment of Efficacy by Physician(Baseline up to Year 4.75)
- Subjective Assessment of Ease of Use by Participant(Baseline up to Year 4.75)