Prospective,open-label,uncontrolled,phase III study to assess the efficacy, safety and pharmacokinetics of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during and after surgery in paediatric subjects with congenital fibrinogen deficiency

Octapharma0 个研究点目标入组 3 人开始时间: 待定最近更新: 2018年2月22日

试验速览

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•age 6-12; documented diagnosis of congenital fibrinogen deficiency; Historical plasma fibrinogen activity of <50ml/dl; expected to have an acute bleeding episode(spontaneous or after trauma) or planing to undergo elective surgery; Informed consent signed by the subject's legal guardian
•Life expectancy<6 months; bleeding disorder other than congenital fibrinogen dificiency; prophylactic treatment with a fibrinogen concentrate; any fibrinogen concentrate or other fibrinogen-containing blood product within 2 weeks prior to start of treatment for the PK phase,a bleeding episode, or surgery; any coagulation drug within 1 week prior to start of PK phase or treatment for the bleeding episode or surgery, or as a planned or expected medication during the time period from Day 1 until 24 hourspresence or history of hypersensitivity to study medication,DVT or pulmonary embolism, arterial thrombosis within 1 year prior to start drug infusion,hypersensitivity to human plasma protein,Oesophageal varicose bleeding

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