Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency

Inclusion Criteria: * Documental congenital FXIII deficiency * Normal platelet count and clotting parameters * Adequate renal and hepatic function * If female and of child-bearing potential, negative serum pregnancy test within 7 days of enrollment * If a sexually active male or a sexually active female of child-bearing potential, agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits * Negative drug and alcohol screens Exclusion Criteria: * Received blood products or FXIII concentrates within 4 weeks of study enrollment * Known antibodies to FXIII * Hereditary or acquired coagulation disorder other than FXIII deficiency * Previous history of autoimmune disorders involving autoantibodies e.g., systemic lupus erythematosus * Previous history of thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis or administration of any antithrombotic or antiplatelet drugs within 7 days of study enrollment * Received treatment with any experimental agent within 30 days of study enrollment * Any surgical procedure in the 30 days prior to enrollment * Donated blood within 30 days prior to enrollment