NCT00916656撤回3 期
Efficacy and Safety of Fibrinogen Concentrate (Human) (FCH) for On-demand Treatment of Acute Bleeding in Subjects With Congenital Fibrinogen Deficiency
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- CSL Behring
- 主要终点
- Clinical assessment of hemostatic efficacy
研究概览
简要总结
This is a multinational, multicenter, prospective, open-label historically controlled Phase IIIb non-inferiority clinical trial on the efficacy and safety of Fibrinogen Concentrate (Human).
It is estimated that 150-300 patients in the U.S. suffer from afibrinogenemia. Substitution with cryoprecipitate or alternative treatments have limited safety and efficacy.
The primary purpose of the study is to demonstrate the hemostatic efficacy of Fibrinogen Concentrate (Human) by adequately controlling acute bleeding (spontaneous or after trauma) in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia). Cryoprecipitate hemostatic efficacy data from a retrospective physician survey will be used as a historical control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia), expected to require treatment for bleeding
- •Presenting with an episode of acute bleeding (either spontaneous or after trauma) not requiring surgery
- •Provide informed consent
排除标准
- •Life expectancy < 6 months
- •Bleeding disorder other than congenital fibrinogen deficiency, but including dysfibrinogenemia
- •Treatment with any investigational medicinal product (IMP) in the 30 days prior to enrollment
- •Treatment with any fibrinogen concentrate or other fibrinogen containing blood product in the 2 weeks prior to enrollment
- •Treatment with any coagulation active drug (i.e., non-steroidal-antirheumatics, warfarin, cumarin derivates, platelet aggregation inhibitors) in 1 week prior to enrollment or as a planned or expected medication during the time period from Day 1 until 24 hours after the last FCH infusion
- •Presence or history of hypersensitivity to FCH
- •Presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment
- •Presence or history of arterial thrombosis within 1 year prior to enrollment
- •Presence or history of hypersensitivity to human plasma proteins
- •Presence or history of esophageal varicose bleeding
- •End stage liver disease (i.e., Child Pugh score B or C)
- •Planned or expected surgery (i.e., for bleedings from aneurysm or splenic rupture)
- •Pregnancy, or an intention to become pregnant during the study
- •Currently breast-feeding, or with the intention of breast-feeding during the study
- •Human immunodeficiency virus (HIV) positive
- •Polytrauma, present or within 6 months prior to enrollment
- •Suspicion of an anti-fibrinogen inhibitor as indicated by previous in-vivo recovery (IVR), if available (< 0.5 (mg/dL)/(mg/kg))
- •Previous inclusion and treatment in the prospective part of the study
- •Participation in any clinical study in the 30 days prior to enrollment
结局指标
主要结局
Clinical assessment of hemostatic efficacy
时间窗: 24 hours after last infusion or at Day 14 (whichever occurs first)
次要结局
- Virus safety markers(Day 1 to Day 45)
- Maximum clot firmness (MCF)(Prior to and 60 minutes after the end of each infusion)
- Fibrinogen plasma level(60 minutes, 3 hours, 6 hours, and 12 hours after the end of the first infusion; before and 60 minutes after each subsequent infusion)
- In vivo recovery of fibrinogen(60 minutes, 3 hours, 6 hours and 12 hours after the end of the first infusion; before and 60 minutes after the end of each subsequent infusion and at the time of the overall clinical assessment of hemostatic efficacy)
研究者
相似试验
进行中（未招募）
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Efficacy and safety of Fibrinogen Concentrate (Human) for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency - NDCongenital fibrinogen deficiency ( afibrinogenemia, severe hypofibrinogenemia)MedDRA version: 9.1Level: LLTClassification code 10016075EUCTR2007-004088-22-ITCSL BEHRING GmbH23
进行中（未招募）
不适用
Efficacy and safety of Fibrinogen Concentrate (Human) for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiencyFibrinogen Concentrate (Human) (FCH) - efficacy and safetyCongenital fibrinogen deficiency (afibrinogenemia, severe hypofibrinogenemia)MedDRA version: 12.0Level: LLTClassification code 10016075Term: Factor I deficiencyEUCTR2007-004088-22-DECSL Behring GmbH23
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