A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-World Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 3
- 主要终点
- Annualised bleeding rate (ABR)
研究概览
简要总结
Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia A and 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 A or B and previously treated with factor Product
- •Have started prophylactic Elocta/Alprolix treatment prior to enrollment visit, or at enrollment prescribed prophylactic treatment with Elocta or 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, from four weeks prior to first injection with Elocta or Alprolix to enrollment visit.
研究组 & 干预措施
Haemophilia A patients
Elocta will be prescribed according to local practice and administered by patients with haemophilia A for prophylactic treatment
干预措施: ELOCTA (Drug)
Haemophilia B 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)
结局指标
主要结局
Annualised bleeding rate (ABR)
时间窗: 24 months
Based on bleeding episodes assessed by local practice
Annualised factor consumption (IU)
时间窗: 24 months
Assessed by dispensed factor product
Annualised injection frequency
时间窗: 24 months
Assessed by prescription
次要结局
未报告次要终点