Status:
RECRUITING
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Von Willebrand Disease, Type 3
Eligibility:
All Genders
2+ years
Brief Summary
This non-interventional study (NIS) is designed to collect information on the effectiveness and safety of treatment received in routine clinical care, as well as measure the health-related quality of ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Type 3 von Willebrand disease (VWD), based on medical records
- Adequate hematologic, hepatic, and renal function
- Documented and confirmed previous use of SOC prophylactic therapy for VWD (1-3 times weekly, as per prescribed dose) and anticipation to remain on the same regimen during the study
- For participants of childbearing potential: agreement to remain abstinent or adhere to the contraception requirements
Exclusion
- Inherited or acquired bleeding disorder other than Congenital Type 3 VWD
- History of gastrointestinal bleeding within 18 months prior to enrollment, or any previous diagnosis of angiodysplasia
- History of intracranial hemorrhage
- Previous or current treatment for thromboembolic disease or signs of thromboembolic disease
- Other conditions (e.g., certain autoimmune diseases) that may increase risk of bleeding or thrombosis
- History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
- Use of systemic immunomodulators (e.g., interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy
Key Trial Info
Start Date :
April 29 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06883240
Start Date
April 29 2025
End Date
November 1 2026
Last Update
December 23 2025
Active Locations (27)
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1
UC Davis
Sacramento, California, United States, 95817
2
University of Florida
Gainesville, Florida, United States, 32610
3
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110