Status:
ACTIVE_NOT_RECRUITING
ATHN 9: Severe VWD Natural History Study
Lead Sponsor:
American Thrombosis and Hemostasis Network
Collaborating Sponsors:
Takeda
Conditions:
Von Willebrand Diseases
Eligibility:
All Genders
Brief Summary
ATHN 9 is a natural history study to assess the safety of various Von Willebrand Factor (VWF) regimens for different indications (on-demand, surgery and prophylaxis) in adult and pediatric participant...
Detailed Description
The overarching objective of this longitudinal, observational and prospective study is to characterize the safety and effectiveness of factor replacement in participants with clinically severe congeni...
Eligibility Criteria
Inclusion
- Participants with severe Von Willebrand Disease with Type 3 VWD or VWF:RCo, VWF:GPlbM or VWF:Ag ≤30% of pooled normal control plasma on more than one occasion;
- Participants with clinically severe VWD as defined by VWF:RCo, VWF:GPlbM or VWF:Ag ≤40% of normal with severe bleeding phenotype defined as requiring recurrent use of factor concentrates; and
- Co-enrollment in the ATHNdataset.
Exclusion
- Diagnosis of platelet-type VWD;
- Diagnosis of acquired VWD (clinical diagnosis based on association with hypothyroidism, lymphoproliferative and myeloproliferative disorders, malignancies and cardiovascular disease, typically aortic stenosis or LVAD).
Key Trial Info
Start Date :
June 18 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 30 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03853486
Start Date
June 18 2019
End Date
July 30 2026
Last Update
March 12 2025
Active Locations (22)
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1
Center for Inherited Blood Disorders
Orange, California, United States, 92868
2
University of Colorado Denver Hemophilia and Thrombosis Center
Aurora, Colorado, United States, 80045
3
Connecticut Bleeding and Clotting Disorders Center
Farmington, Connecticut, United States, 06030
4
University of Florida Hemophilia Treatment Center
Gainesville, Florida, United States, 32610