Hemophilia Inhibitor PUP Study - HIPS

und University, Clinical Coagulation Research Unit, Skane University Hospital0 个研究点目标入组 50 人开始时间: 2014年9月19日最近更新: 2014年12月1日

适应症

试验速览

暂无简介。

•1) An informed consent, approved by the appropriate institutional Review Board (IRB)/Independent Ethics Committee (IEC) has been administered, signed and dated by the parents or legal representative of the parents
•2) Subject diagnosed with severe hemophilia A defined by baseline FVIII:C <0.01 IU/mL. FVIII activity has to be confirmed by a central lab. If the confirmatory level is not <0.01IU/mL the child must exit the study.
•3) Subject weighs 3.5 kg or more at the time of his baseline study evaluation
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 50
•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

•1) Subjects with prior exposure to clotting factor concentration or blood products.
•2) Subjects with a clinically significant chronic disease other than hemophilia A
•3) Subjects that are currently participating in another investigational clinical trial

发起方

und University, Clinical Coagulation Research Unit, Skane University Hospital