drugset / Trial / NCT06205095
A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients with VWD
RandomizedCrossoverTriple-blindTreatment
Summary
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
Timeline
- Start
- 2024-10-21
- Primary completion
- 2026-09
- Completion
- 2026-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Wilate | Protein / enzyme biologic | 30 iu/kg | Intravenous |
| Subject | Wilate | Protein / enzyme biologic | 60 iu/kg | Intravenous |