EUCTR2013-000261-36-Outside-EU/EEA进行中（未招募）不适用
Clinical pharmacology, efficacy and safety study of FGTW in paediatric patients with severe congenital fibrinogen deficiency
FB Biotechnologies0 个研究点目标入组 12 人开始时间: 2014年4月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed and dated informed consent form by parents or a legal representative
- •2. Age 12 years old
- •3. Patients with inherited afibrinogenaemia (fibrinogen antigen levels 0.2 g/L and unclottable PT, aPTT and TT) or severe hypofibrinogenaemia defined as fibrinogen antigen levels 0.5 g/L and activity to antigen ratio ˜ 1
- •4. Negative results on HCG-based pregnancy test at the selection visit, before PK/PD part and before each event to be treated for females of childbearing potential (presence of menstruation)
- •5. Covered by healthcare insurance in accordance with local requirements
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Dysfibrinogenaemia
- •2. Acquired fibrinogen deficiency
- •3. Suspected present or past anticoagulation inhibitor
- •4. Personal history of venous or arterial thrombosis or thromboembolic event
- •5. Co-morbidity with other/unrelated coagulopathies
- •6. Administration of any fibrinogen concentrate or fibrinogen containing blood product during the last 15 days (applicable only if fibrinogen levels to be measured at inclusion)
- •7. Platelet count less than 100 x 109/L
- •8. Serum creatinine > 2 times the upper limit of normal
- •9. AST and / or ALT > 5 times the upper limit of normal
- •10. Known history of hypersensitivity or other severe reaction to any component of the investigational medicinal product
- •11. Any other condition which, in the opinion of the investigator, could interfere with the study results or would not be in the best interest of the patient.
- •12. Participation in another drug clinical trial at the same time or within the previous 30 days
- •13. Anticipated poor compliance with study procedures
- •14. Legal incapacity or limited capacity
- •15. Permanent treatment with antithrombotic or anti-platelet agents such as heparins, anti-IIa or anti-Xa agents, aspirin, clopidogrel and NSAIDs.
- •Additional exclusion criteria specific to PK/PD Part
- •1. Patients with hypofibrinogenaemia defined as fibrinogen antigen levels 0.5 g/L and activity to antigen ratio ˜ 1
- •2. Significant bleeding(s) within 7 days prior to the start of the PK/PD part that could have an impact on the patient's plasma volume
- •3. Administration of any fibrinogen concentrate or fibrinogen containing blood product during the last 15 days prior to the start of the PK/PD part
- •4. Treatment with antithrombotic or anti-platelet agents such as heparins, anti-IIa or anti-Xa agents, aspirin, clopidogrel and NSAIDs within 10 days prior to the start of the PK/PD part.
- •5. Elective surgery within 14 days after administration of FGTW for PK/PD part
研究者
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