NCT02634723已完成不适用
Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A
Baxalta now part of Shire6 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年12月23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
- 21
- 试验地点
- 6
- 主要终点
- Number and type of other serious and non-serious adverse events (AEs)
研究概览
简要总结
The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to severe hemophilia A.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated patient (PUP) in China with moderate to severe hemophilia A.
- •Investigator prescribed ADVATE as the predominant therapeutic agent for the management of hemophilia A
- •Informed consent form from patient and/or legal representative will need to be signed per local regulation
排除标准
- •Presence of an inherited or acquired hemostatic defect other than hemophilia A, and any other clinically significant chronic disease
- •Participants who participated in another investigational FVIII drug study, or had participated in any clinical study involving an investigational FVIII drug during the course of the observation period
结局指标
主要结局
Number and type of other serious and non-serious adverse events (AEs)
时间窗: Throughout the study period of 6 months
Other AEs refers to AEs other than Factor VIII (FVIII) inhibitors
Number of high titer, low titer and transient Factor VIII (FVIII) inhibitors developed
时间窗: Throughout the study period of 6 months
次要结局
- Total number of exposure days (EDs) to ADVATE(Throughout the study period of 6 months)
- Number of bleeding episodes treated with 1, 2, 3, ≥ 4 infusions of ADVATE(Throughout the study period of 6 months)
- Annualized joint bleeding rate (AJBR) of participants treated prophylactically and on-demand with ADVATE(Throughout the study period of 6 months)
- Total units of all Factor VIII (FVIII) products administered(Throughout the study period of 6 months)
- Total units of ADVATE administered(Throughout the study period of 6 months)
- Number and type of bleeding episodes treated with ADVATE(Throughout the study period of 6 months)
- Annualized bleeding rate (ABR) of participants treated prophylactically and on-demand with ADVATE(Throughout the study period of 6 months)
- Total number of exposure days (EDs) to all Factor VIII (FVIII) products(Throughout the study period of 6 months)
研究者
研究点 (6)
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