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