Lead Sponsor

Novo Nordisk A/S

Age

1 - 6 years

Sex

ALL

Healthy Volunteers

No

•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

•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

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