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