Post Marketing Surveillance Study for ADYNOVATE in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 341
- 试验地点
- 8
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The main aim of this study is to check for side effects and medical problems in participants with hemophilia A who are receiving ADYNOVATE in routine clinical practice. Also, it will be checked how effective ADYNOVATE is at stopping a bleed, at preventing bleeding episodes when used routinely for prevention and at controlling hemophilia-related bleeding during surgeries.
Participants with hemophilia A who will be newly prescribed with ADYNOVATE treatment or have already been taking ADYNOVATE treatment according to the physician's decision will be included in this study.
Participants will visit the study clinic as a part of their routine clinical practice and will be contacted by phone calls/home visits by home care workers for collection of treatment related data during the 6-month observation period.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of adverse events
时间窗: Throughout the duration of patient participation of up to approximately 6 months
Serious adverse events and non-serious adverse events
Frequency of adverse events
时间窗: Throughout the duration of patient participation of up to approximately 6 months
Serious adverse events and non-serious adverse events
次要结局
- Number of treated bleeds(Throughout the duration of patient participation of up to approximately 6 months)
- ADYNOVATE units required for bleed resolution(At bleed resolution, throughout the duration of patient participation of up to approximately 6 months)
- Clinically significant changes in laboratory results(Throughout the duration of patient participation of up to approximately 6 months)
- Incidence of inhibitor titers for FVIII antibodies(Throughout the duration of patient participation of up to approximately 6 months)
- Assessment of perioperative effectiveness of ADYNOVATE(Throughout the duration of patient participation of up to approximately 6 months)
- Hemostatic effectiveness assessment of bleeding episodes treated with ADYNOVATE during prophylaxis treatment(Throughout the duration of patient participation of up to approximately 6 months)
- Hemostatic effectiveness of ADYNOVATE for participants on an on-demand regimen(At bleed resolution, throughout the duration of patient participation of up to approximately 6 months)
- Number of ADYNOVATE infusions needed for the treatment of bleeding episodes(At bleed resolution, throughout the duration of patient participation of up to approximately 6 months)