Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)

Key Inclusion Criteria: Subjects of any age Clinical and laboratory diagnosis of vWD that can be expected to show no hemostatic response to DDAVP Require substitution with vWF/FVIII complex due to a surgery Key Exclusion Criteria: Known significant hemostatic disorder other than vWD Acquired vWD Known antibodies to FVIII or vWF Known platelet type vWD Emergency surgery or any surgery with a degree of urgency not permitting completion of a pharmacokinetic assessment required by the study protocol History of allergic reaction to Humate-P® Treatment with any other investigational drug in the last four weeks before the entry into the study (with exception of trials concerning anti-HIV agents) Progressive fatal disease/life expectancy of less than 6 months Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or vWF within 5 days of the pre-surgical pharmacokinetic assessment Pediatric patients of insufficient body weight to permit PK sampling Woman in the first 20 weeks of pregnancy