NCT06205095View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 21, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Von Willebrand Diseases
Interventions
DRUG

Lyophilized concentrate of human coagulation von Willebrand Factor and factor VIII

Wilate® is a plasma-derived, highly purified concentrate administered through intravenous injection. Wilate® contains an average VWF ristocetin cofactor activity to FVIII activity at ratio of 1:1.

OTHER

Placebo

Patients randomized to the placebo arm will receive intravenous normal saline at the same approximate volume and frequency of Wilate ®.

Trial Locations (1)

M5B1W8

RECRUITING

St. Michael's Hospital, Toronto

All Listed Sponsors
lead

Unity Health Toronto

OTHER