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

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