The EMPOWER trial is a pilot multi-center, placebo-controlled (normal saline), double-blind (patient and outcome assessor), crossover, 2-year randomized trial in female outpatients with von Willebrand disease (VWD) and heavy menstrual bleeding to determine trial feasibility and viability, and to explore assay sensitivity of the proposed efficacy clinical outcomes for a definitive randomized controlled trial
Patient capable of providing informed consent;
Female patients with HMB over the age of 18 years, for whom prophylactic treatment with Wilate® is deemed clinically appropriate according to the medical discretion (based on their expert opinion given consideration of the patient's bleeding history and responsiveness to treatment) of the treating hemostasis-focused physician practicing at a Hemophilia Treatment Center;
Modified PBAC score > 100 at screening;
Patients with a diagnosis of inherited von Willebrand disease (any type);
Diagnosed with any other known bleeding disorder;
Pregnancy or plans to become pregnant within the duration of the study;
Breastfeeding or plans to breastfeed within the duration of the study;
Known hypersensitivity reactions to human plasma-derived products or any ingredient in the formulation;