A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency

Exclusion Criteria

• •Diagnosis of acquired FXIII deficiency
• •Administration of a FXIII-containing product, including blood transfusions or other blood products within 4 weeks prior to the planned Day 0
• •Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
• •Known or suspected to have antibodies towards FXIII
• •Use of any other investigational medicinal product within 4 weeks prior to the Baseline Visit (Day 0)
• •Positive result at screening for human immunodeficiency virus (HIV)
• •Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) concentration \>2.5 times the upper limit of normal
• •Fibrinogen \< lower limit of normal
• •Active bleeding
• •Pregnant or breast-feeding
• •Intention to become pregnant during the course of the study
• •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
• •Surgical procedure anticipated during the study period
• •Suspected inability (e.g., language problems) or unwillingness to comply with study procedures or history of noncompliance