To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)

Exclusion Criteria

• •Hereditary or acquired coagulation disorder other than VWD (including qualitative and quantitative platelet disorders, and thrombocytopenia \< 100,000 cells/uL at Screening)
• •The participant has a FVIII activity levels \>20 IU/dL, at Screening
• •History or presence of a VWF inhibitor or clinical suspicion of a VWF inhibitor
• •History of a positive FVIII inhibitor test, defined as ≥0.6 BU/mL (by Nijmegen modified Bethesda assay) or a clinical suspicion of a FVIII inhibitor
• •Positive FVIII inhibitor test, defined as ≥0.6 BU/mL, at Screening
• •History of hypersensitivity or anaphylaxis associated with any FVIII- or VWF- containing product
• •The participant has received or anticipates receiving systemic immunosuppressive or immunomodulatory treatment within 12 weeks prior to Baseline.
• •The participant requires the use of acetylsalicylic acid, non-NSAID anti-platelets, and NSAIDs above the maximum dose product
• •Patients currently on a prophylaxis regimen for the treatment of VWD that, in the Investigator's opinion, would preclude participation in the study due to the possible increased risk of bleeding associated with the requirement to withhold prophylaxis during the study.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.