EUCTR2011-002403-15-IT进行中（未招募）不适用
A prospective, controlled, randomised, cross-over study investigating the pharmacokinetic properties, surrogate efficacy and safety of Octafibrincompared to Haemocomplettan® P/ RiaSTAPTM in subjects with congenital fibrinogen deficiency
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
- •Subject age =12 years
- •Documented congenital fibrinogen deficiency (afibrinogenaemia)
- •Plasma fibrinogen activity and antigen at screening bellow detection limit (i.e. <20mg/dl)
- •Informed consent signed by subject or legal guardian
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Life expectancy <6 months
- •Bleeding disorder other than congenital fibrinogen deficiency
- •Dysfibrinogenemia
- •Treatment with:
- •Any fibrinogen concentrate or other fibrinogen-containing blood product in the 2 weeks prior to enrolment
- •Presence or history of:
- •Hypersensitivity to study medication
- • Deep vein thrombosis or pulmonary embolism within 1 year prior to enrolment
- • Arterial thrombosis within 1 year prior to enrolment
- • Hypersensitivity to human plasma proteins
- •? Acute bleeding
- •? History of oesophageal varicose bleeding
- •? End-stage liver disease (i.e. Child-Pugh-score B or C)
- •? Planned major surgery with a need for blood transfusion during the PK blood-sampling period of this study
- •? Pregnancy, or an intention to become pregnant during the study
- •? Currently breast-feeding, or with the intention of breast-feeding during the study
- •? HIV positive with a viral load >200 particles/µl ~ >400000 copies/ml
- •? Polytrauma 1 year prior to enrolment
- •? Suspicion of an anti-fibrinogen inhibitor as indicated by previous in-vivo recovery, if available 0.5 (mg/dl)/(mg/kg), (there is currently no standard test for inhibitors)<br? Blood or plasma donation in the 3 months prior to enrolment
研究者
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