A Multicenter Study on the Retrospective Safety and Efficacy of Fibrinogen Concentrate (Human) (FCH) for Routine Prophylaxis, Treatment of Bleeding or Surgery in Subjects With Congenital Fibrinogen Deficiency With a Prospective Followup Component
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Percentage of participants achieving hemostatic efficacy - retrospective
研究概览
简要总结
This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency. Data will be collected on the safety and efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis and perioperative bleeding in these subjects. All subjects have received FCH and may continue to receive FCH at the discretion of the treating physician / Primary Investigator according to the standard of care at the participating study site.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects of any age with a diagnosis of congenital fibrinogen deficiency.
- •Have received FCH (Haemocomplettan® P or RiaSTAP®) for treatment of bleeding, surgery or prophylaxis.
排除标准
- 未提供
结局指标
主要结局
Percentage of participants achieving hemostatic efficacy - retrospective
时间窗: From the subject's first use of FCH, up to approximately 20 years.
The investigator's overall assessment of hemostatic efficacy of FCH from a review of the subject's historical records.
次要结局
- Percentage of participants with adverse events(Retrospective data collection is from the subject's first use of FCH (up to approximately 20 years); Prospective data collection is from the time of informed consent up to approximately 12 months.)
- Percentage of participants achieving hemostatic efficacy - prospective(Approximately 12 months)