Actively Recruiting
A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients with VWD
Led by Unity Health Toronto · Updated on 2024-12-24
20
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients with VWD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient capable of providing informed consent
- Female patients with heavy menstrual bleeding (HMB) over the age of 18 years
- Modified PBAC score over 100 at screening
- Diagnosis of inherited von Willebrand disease (any type)
- Stable treatment for HMB and iron deficiency anemia for 3 cycles before entering the study, expected to remain unchanged
- Willingness to have an infusion administered by a nurse during the study
- Agreement to use only the feminine hygiene products supplied by the sponsor
You will not qualify if you...
- Diagnosis of any other known bleeding disorder
- Pregnancy or plans to become pregnant during the study
- Breastfeeding or plans to breastfeed during the study
- Known hypersensitivity to human plasma-derived products or any ingredients
- Known antibodies to von Willebrand factor or factor VIII
- Severe liver disease
- Planned start of hormonal contraceptives, GnRH analogues, or hormonal intrauterine device during the study
- Planned elective procedure requiring intensive von Willebrand factor or factor VIII treatment for more than 10 days during the study
- More than 2 risk factors for venous thromboembolism or recent thrombosis within the last year
- Concurrent use of desmopressin except for escalation treatment of excessive bleeding
- Planned start of any new therapies for heavy menstrual bleeding within 3 weeks before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Actively Recruiting
Research Team
S
St. Michael's Hospital
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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