NCT01790828已完成不适用
Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha 'Registered' In Subjects With Hemophilia A
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Percentage of Participants by Family History of Factor VIII Inhibitor
研究概览
简要总结
This study is to describe the safety and efficacy of Xyntha® during the usual care setting.
详细描述
non probability sample
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients or legally authorized representatives of pediatric patients agree to provide written informed consent form (data privacy statement).
- •Pediatric and adult patients who have been treated with Xyntha for Hemophilia A from first approved date by KFDA, or who are planned to be newly prescribed Xyntha.
排除标准
- •Patients with a known history of hypersensitivity to original or reformulated Xyntha or any component of the product.
- •Patients with a known history of hypersensitivity to hamster protein.
- •Patients participating in an interventional trial of any investigational drug or device.
结局指标
主要结局
Percentage of Participants by Family History of Factor VIII Inhibitor
时间窗: 4 years
次要结局
- Average Infusion Dose During Prophylaxis (All Participants)(4 years)
- Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)(4 years)
- Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age(4 years)
- Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age(4 years)
- Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants)(4 years)
- Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants <18 Years of Age(4 years)
- Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants ≥18 Years of Age(4 years)
- Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha(4 years)
- Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants)(4 years)
- Annualized Bleeding Rates During Prophylaxis(4 years)
- Average Infusion Dose During Prophylaxis in Participants <18 Years of Age(4 years)
- Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age(4 years)
- Percentage of Participants Experiencing Hemorrhages During Prophylaxis(4 years)
- Number of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy(4 years)
- Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants)(4 years)
- Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age(4 years)
- Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age(4 years)
- Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age(4 years)
- Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age(4 years)
研究者
研究点 (4)
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