A Multinational, Prospective, Open Labelled, Non-controlled, Non-interventional Post-authorisation Study of Turoctocog Alfa Pegol (N8-GP) During Long-term Routine Prophylaxis and Treatment of Bleeding Episodes in Patients With Haemophilia A
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 25
- 主要终点
- Number of Adverse Events (AEs) reported during the study period
研究概览
简要总结
This study will collect information on side effects and how well Esperoct® (turoctocog alfa pegol (N8-GP)) works during long-term treatment (prophylaxis) in males with haemophilia A. Participants in this study will get the same treatment as they would normally get, if they were not participating in the study. All visits at the clinic are done in the same way as participants are used to, when visiting their doctor. During visits at the clinic participants might be asked for some relevant tests if considered useful by the study doctor. During the visits the study doctor might ask if participants had any side effects since the last study visit. Participants will be asked to note down in their own diary the number of bleeds and how these were treated, as well as their regular prophylaxis. Participation in the study will last for about 5-7 years, depending on when participants join the study. Participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.
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
- •Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- •The decision to initiate treatment with commercially available Esperoct® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
- •Male patients of all ages, according to local label, are allowed in this study
- •Diagnosis of severe or moderate Haemophilia A
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study
- •Known or suspected hypersensitivity to N8-GP or related products
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding and cooperation
- •Clinical suspicion or presence of FVIII inhibitors at time of inclusion
研究组 & 干预措施
N8-GP
Patients with haemophilia A
干预措施: Turoctocog alfa pegol (N8-GP) (Drug)
结局指标
主要结局
Number of Adverse Events (AEs) reported during the study period
时间窗: From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years
Count of events
次要结局
- Number of Serious Adverse Events (SAEs) reported during the study period(From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years)