NCT04334057已完成不适用
Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®. A Multi-centre, Prospective, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Effectiveness of Esperoct® in Haemophilia A Patients Under Routine Clinical Practice Conditions in Japan
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 19
- 主要终点
- Number of adverse reactions (ARs) reported during the observation period
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of Esperoct® for long-term routine use in patients with Haemophilia A. Participants will get Esperoct® as prescribed by their doctor. The study will last for about 2 years for each participant.
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
- •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.
- •Diagnosis of haemophilia A in males or females, no age limitation.
- •New patients who have not previously been exposed to Esperoct®.
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 study product or related products.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
研究组 & 干预措施
Patients with haemophilia A
New patients who have not previously been exposed to Esperoct® (Turoctocog alfa pegol or N8-GP in clinical trials) are eligible for this study.
干预措施: Turoctocog alfa pegol (Drug)
结局指标
主要结局
Number of adverse reactions (ARs) reported during the observation period
时间窗: From baseline (week 0) to end of study (week 104)
Count
次要结局
- Number of serious adverse events (SAEs) reported during the observation period(From baseline (week 0) to end of study (week 104))
- Number of patients who have confirmed inhibitory antibodies against FVIII during the observation period(From baseline (week 0) to end of study (week 104))
- Evaluation of the haemostatic response of Esperoct® measured as number of successes in treatment of bleeds in perioperative management during surgical procedures(From baseline (week 0) to end of study (week 104))
- Number of serious adverse reactions (SARs) reported during the observation period(From baseline (week 0) to end of study (week 104))
- Number of bleeding episodes requiring treatment for patients using Esperoct® during the observation period assessed by annual bleeding rate (ABR)(From baseline (week 0) to end of study (week 104))
- Evaluation of the haemostatic response of Esperoct® measured as number of successes for treatment requiring bleeds(From baseline (week 0) to end of study (week 104))
研究者
研究点 (19)
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