A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 3
- 主要终点
- Amount of factor Product used to treat a bleed (on-demand treatment)
研究概览
简要总结
Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic treatment of haemophilia B.
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
- •Have a diagnosis of haemophilia B and been treated previously with factor IX Product
- •Have started Alprolix treatment prior to enrolment visit, or at enrolment prescribed treatment with Alprolix, regardless of participation in the study
- •Signed and dated informed consent provided by the patient, or the patient's legally acceptable representative for patients under the legal age, before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations
排除标准
- •Participation in an investigational medicinal product trial at enrolment visit
研究组 & 干预措施
Prophylactic patients
Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment
干预措施: Alprolix (Drug)
On demand patients
Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for on-demand treatment
干预措施: Alprolix (Drug)
结局指标
主要结局
Amount of factor Product used to treat a bleed (on-demand treatment)
时间窗: 24 months
Assessed by diary
Annualised bleeding rate (ABR) (prophylactic treatment)
时间窗: 24 months
Assessed by diary
Annualised injection frequency (prophylactic treatment)
时间窗: 24 months
Assessed by diary
Number of injections to treat a bleed (on-demand treatment)
时间窗: 24 months
Assessed by diary
Annualised factor consumption (International Unit [IU]) (prophylactic treatment)
时间窗: 24 months
Assessed by diary
次要结局
未报告次要终点