NCT02094430已完成2 期
Clinical Pharmacology, Efficacy and Safety Study of FGTW in Paediatric Patients With Severe Congenital Fibrinogen Deficiency
Laboratoire français de Fractionnement et de Biotechnologies5 个研究点 分布在 4 个国家目标入组 16 人开始时间: 2014年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 5
- 主要终点
- Investigator's overall assessment of efficacy of FGTW on hemostasis using a 4-point scale at the end of each bleeding or surgical episode.
研究概览
简要总结
The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in pediatric patients with congenital fibrinogen deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form by parents or a legal representative
- •Age less or equal to 12 years old
- •Patients with inherited afibrinogenemia or severe inherited hypofibrinogenemia
- •Negative results on HCG-based pregnancy test for females of childbearing potential (presence of menstruation)
排除标准
- •Dysfibrinogenemia
- •Acquired fibrinogen deficiency
- •Suspected present or past anticoagulation inhibitor
- •Personal history of venous or arterial thrombosis or thromboembolic event
- •Co-morbidity with other/unrelated coagulopathies
- •Administration of any fibrinogen concentrate or fibrinogen containing blood product during the last 15 days
- •Permanent treatment with antithrombotic or anti-platelet agents such as heparins, anti-IIa or anti-Xa agents, aspirin, clopidogrel and NSAIDs.
结局指标
主要结局
Investigator's overall assessment of efficacy of FGTW on hemostasis using a 4-point scale at the end of each bleeding or surgical episode.
时间窗: 6 hours or up to 5 days
Terminal half life for Fibrinogen antigen and activity
时间窗: 5 days
次要结局
- Adverse Events(Participants will be followed for the duration of their participation in the study, an expected average of 1 year)
研究者
研究点 (5)
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