Study of the Pharmacokinetics and Safety of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) in Patients With Congenital Factor VII Deficiency

Inclusion Criteria: * Proven congenital FVII deficiency. * Age ≥ 18 years. * FVII level \< 2% of normal levels. * Minimum of 50 previous exposure days to pdFVII (including prothrombin complex concentrates \[PCCs\]) or rFVIIa. Exclusion Criteria: * History of, or risk factors for, thromboembolic events, including known deep vein thrombosis. * Inhibitor to FVII or rFVIIa, current or historic. * Known or suspected hypersensitivity to hamster protein, to CSL689, or to any excipient of CSL689. * Known or suspected allergy to rFVIIa or hamster protein. * Major surgery within 1 month before screening. * Advanced atherosclerotic disease (ie, known history of ischemic heart disease, or ischemic stroke). * Human immunodeficiency virus (HIV)-positive subjects with cluster of differentiation 4 (CD4)+ lymphocyte count of \< 200/µL at screening. * Use of an investigational agent within 30 days before the study. * Use of concomitant therapy not permitted during the study (ie, other platelet inhibitors, desmopressin, fibrinolysis inhibitors, except if used as local treatment \[eg, for oral bleeds\])