An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

Inclusion Criteria: * Written informed consent/assent for study participation obtained before undergoing any study specific procedures * Diagnosed with congenital FXIII deficiency requiring prophylactic treatment * Males and females of any age Exclusion Criteria: * Diagnosis of acquired FXIII deficiency * Administration of a FXIII-containing product, including blood transfusions or other blood products, within 3 weeks prior to the Baseline/Day 0 Visit * Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency * Use of any other IMP within 4 weeks prior to Baseline/Day 0 Visit * Female subjects of childbearing potential not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study * Suspected inability (e.g., language problems) or unwillingness to comply with study procedures or history of noncompliance * Any laboratory finding or medical condition which, in the opinion of the Investigator, would put the subject or subject's disease management at risk