NCT02922231已完成不适用
Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
Baxalta now part of Shire5 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2017年1月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 5
- 主要终点
- Number of adverse events (AEs)
研究概览
简要总结
Primary: To characterize the safety of RIXUBIS when used under normal clinical care in South Korea.
Secondary: To describe hemostatic effectiveness in subjects receiving RIXUBIS under normal clinical care in South Korea.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with congenital hemophilia B (FIX level ≤5%)
- •Participant or the participant's legally authorized representative has provided signed informed consent.
- •Participant is indicated for treatment according to the RIXUBIS Korean product leaflet.
排除标准
- •Participants with known hypersensitivity or presence of any contraindication to RIXUBIS or its excipients including hamster protein
- •Participants with Disseminated Intravascular Coagulation (DIC)
- •Participants with signs of fibrinolysis
结局指标
主要结局
Number of adverse events (AEs)
时间窗: Throughout the study period of approximately 2 years and 6 months
Seriousness and severity of AEs, including any inhibitory antibody development and/or anaphylactic reactions
次要结局
- Physician rated effectiveness of RIXUBIS for prophylactic treatment in participants <12 years old(Up to 6 months from baseline while on treatment)
- Participant rated effectiveness of RIXUBIS for prophylactic treatment in participants ≥12 years old(Up to 6 months from baseline while on treatment)
- Physician rated effectiveness of RIXUBIS for on-demand treatment in participants <12 years old(Up to 6 months from baseline while on treatment)
- Participant rated effectiveness of RIXUBIS for on-demand treatment in participants ≥12 years old(Up to 6 months from baseline while on treatment)
研究者
研究点 (5)
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