drugset / Trial / NCT06205095

A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients with VWD

NCT06205095

Phase 3 Recruiting 20 enrolled Unity Health Toronto
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

EvaluationDrugModalityDoseRoute
Subject Wilate Protein / enzyme biologic 30 iu/kg Intravenous
Subject Wilate Protein / enzyme biologic 60 iu/kg Intravenous