NCT01127529已完成不适用
Ceprotin Treatment Registry
Baxalta now part of Shire0 个研究点目标入组 43 人开始时间: 2010年6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
- 43
- 主要终点
- Ceprotin treatment regimens
研究概览
简要总结
The overall objective is to collect and assess data on the treatment, safety, and treatment outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment registry.
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
- •Participants for whom CEPROTIN therapy has been indicated and meeting the following criteria may be enrolled in this study:
- •Signed and dated informed consent from either the participant or the participant's legally authorized representative prior to enrollment, as applicable
- •Males and females of any age, including neonates, children, adolescents and adults
- •Participant who received CEPROTIN or is initiating/receiving CEPROTIN treatment
排除标准
- 未提供
结局指标
主要结局
Ceprotin treatment regimens
时间窗: 2 to 5 years, or until the Registry is terminated
Safety information based on all serious adverse events (SAEs), related SAEs and related non-serious adverse events (AEs)
时间窗: 2 to 5 years, or until the Registry is terminated
Medical diagnoses associated with Ceprotin treatment
时间窗: 2 to 5 years, or until the Registry is terminated
次要结局
- CEPROTIN use and treatment outcomes in pregnancy, labor and delivery, surgery and invasive procedures, different age groups, and, in the presence of pre-existing renal and/or hepatic dysfunction(2 to 5 years, or until the Registry is terminated)
- Treatment outcomes categorized by medical diagnosis(2 to 5 years, or until the Registry is terminated)
研究者
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