Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency

Exclusion Criteria

• •Known or suspected hypersensitivity to trial product or related products
• •Known history of development of inhibitors against FXIII (factor XIII)
• •Hereditary or acquired coagulation disorder other than FXIII congenital deficiency
• •Platelet count (thrombocytes) less than 50X10e9 / L
• •Previous history of autoimmune disorder involving autoantibodies e.g., systemic lupus erythematosus
• •Previous history of arterial or venous thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis
• •Any disease or condition which, judged by the trial physician, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome including renal and/or liver dysfunction