Status:
RECRUITING
A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients with VWD
Lead Sponsor:
Unity Health Toronto
Conditions:
Von Willebrand Diseases
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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);
- Stable treatment for HMB and iron deficiency anemia for 3 cycles before entering the study and anticipated to remain unchanged for the duration of the study;
- Patients willing to have an infusion administered by a nurse over the course of the study period;
- Patients who agree to use only the feminine hygiene products supplied by the sponsor.
Exclusion
- 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;
- Known antibodies to VWF or FVIII;
- Severe liver disease;
- Anticipated initiation of the following: oral, transdermal, injectable, and vaginal ring hormonal contraceptives; GnRH analogues; or a hormonal intrauterine device (IUD) within the study period;
- Anticipated elective procedure that is expected to require intensive treatment with VWF or FVIII for \>10 days during the study period;
- Patients with \>2 risk factors for VTE (risk factors are determined at discretion of treating physician) or recent history of thrombosis (i.e. within the last year).
- Patient concurrently receiving desmopressin (desmopressin cannot be taken concurrently with Wilate®, except for in the context of escalation treatment for excessive bleeding).
- Anticipated initiation of any new therapies for the treatment of heavy menstrual bleeding 3 weeks prior to enrollment
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06205095
Start Date
October 21 2024
End Date
September 1 2026
Last Update
December 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8