A Phase 3 Clinical Study to Determine the Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor : Recombinant Factor VIII (rVWF:rFVIII) and rVWF in the Treatment of Bleeding Episodes in Subjects Diagnosed With Von Willebrand Disease

Selected

Inclusion Criteria:

- The subject has been diagnosed with type 3 von Willebrand disease (VWD:Ag <= 3 IU/dl)
or severe non-type 3 VWD (VWF:RCo < 20 IU/dL) or type 2N VWD (FVIII:C <10% and
historically documented genetics)

- The subject, who participates for the treatment of bleeding episodes, has had a
minimum of 6 documented bleeds (medical history) requiring VWF coagulation factor
replacement therapy during the previous 3 years prior to enrollment

- The subject is at least 18 and not older than 65 years of age at enrollment

Selected Exclusion Criteria:

- The subject has been diagnosed with pseudo VWD or another hereditary or acquired
coagulation disorder other than VWD (e.g., qualitative and quantitative platelet
disorders or elevated PT/international normalized ratio [INR] > 1.4)

- The subject has a documented history of a VWF:RCo half-life of < 6 hours

- The subject has a history or presence of a VWF inhibitor at screening

- The subject has a history or presence of a factor VIII (FVIII) inhibitor with a titer
>= 0.4 BU (by Nijmegen assay) or >= 0.6 BU (by Bethesda assay)