rVWF IN PROPHYLAXIS

Inclusion Criteria

• Participant has a documented diagnosis of severe von Willebrand disease (VWD) (baseline Von Willebrand factor: Ristocetin cofactor activity (VWF:RCo) less than ( or=) 3 documented spontaneous bleeds (not including menorrhagia) requiring von Willebrand factor (VWF) treatment during the past 12 months.
• Availability of records to reliably evaluate type, frequency and treatment of bleeding episodes during at least 12 months preceding enrollment. Up to 24 months retrospective data should be collected if available. Availability of dosing and factor consumption during 12 months (up to 24 months) of treatment prior to enrollment is required for pdVWF switch participants and is desired (but not a requirement) for on-demand participants.
• Participant is > or = 18 years old at the time of screening and has a body mass index > or = 15 but ]1.4).
• The participant is currently receiving prophylactic treatment with more than 5 infusions per week.
• The participant is currently receiving prophylactic treatment with a weekly dose exceeding 240 IU/kg.
• The participant has a history or presence of a VWF inhibitor at screening.
• The participant has a history or presence of a Factor VIII (FVIII) inhibitor with a titer ≥0.4 Bethesda units (BU) (by Nijmegen modified Bethesda assay) or > or = 0.6 Bethesda Unit (BU) (by Bethesda assay).
• The participant has a known hypersensitivity to any of the components of the study drugs, such as to mouse or hamster proteins.
• The participant has a medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, mild asthma, food allergies or animal allergies.
• The participant has a medical history of a thromboembolic event.
• The participant is human immunodeficiency virus (HIV) positive with an absolute Helper T cell (CD4) count or = 2.5 milligram per deciliter (mg/dL).
• The participant has a platelet count <100,000/ milliliter (mL) at screening.
• The participant has been treated with an immunomodulatory drug, excluding topical treatment (e.g., ointments, nasal sprays), within 30 days prior to signing the informed consent.
• The participant is pregnant or lactating at the time of enrollment.
• Patient has cervical or uterine conditions causing menorrhagia or metrorrhagia (including infection, dysplasia).
• The participant has participated in another clinical study involving another Investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
• The participant has a progressive fatal disease and/or life expectancy of less than 15 months.
• The participant is scheduled for a surgical intervention.
• The participant is identified by the investigator as being unable or unwilling to cooperate with study procedures.
• The participant has a mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
• The participant is in prison or compulsory detention by regulatory and/or juridical order.
• The participant is member of the study team or in a dependent relationship with one of the study team members which includes close relatives (i.e., children, partner/spouse, siblings and parents) as well as employees.