A 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 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)
• •Known Positivity for human immunodeficiency virus (HIV) or a positive result for HIV at the Screening Visit of this study or the FXIII study 2002 (NCT00883090).
• •Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) concentration \>2.5 times the upper limit of normal at the Screening Visit of this study or at the Day 56 Visit of Factor XIII Study BI71023\_2002 (NCT00883090)
• •Fibrinogen level less than 85% of the lower limit of normal at the Screening Visit of this study or the Factor XIII Study BI71023\_2002 (NCT00883090)
• •Active bleeding ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 and/or ≥ moderate between the Screening and Baseline Visits
• •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
• •Suspected inability (e.g., language problems) or unwillingness to comply with study procedures or history of noncompliance