Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
1–6
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed Informed Consent by subject's parents or subject's legally acceptable representative before any trial related activities. Trial related activities are any procedures that would not have been performed during the normal management of the subject
Age 1 to less than 6 years old at the time of enrolment
Congenital FXIII subunit-A deficiency previously documented by genotyping or evaluated by genotyping through blood sampling at screening visit
Body weight at least 10 kg
You may not be if
Known antibodies to FXIII
Hereditary or acquired coagulation disorder other than FXIII A-subunit congenital deficiency
Platelet count (thrombocytes) of less than 50 × 10\^9/L (at screening visit)
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
Known or suspected allergy to trial product or related products
Any surgical procedure in the 30 days prior to enrolment and any planned surgery during the trial period
Any disease or condition which, judged by the Investigator, could imply a potential hazard to the subject or interfere with the trial participation or trial outcome including renal and/or liver dysfunction
