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Completed
NCT03853486
ATHN 9: Severe VWD Natural History Study
Conditions: Von Willebrand Diseases
Sex: All
Enrollment: 108
Sponsor: American Thrombosis and Hemostasis Network
Location: Center for Inherited Blood Disorders Orange California
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 participants with clinically severe congenital VWD.
Eligibility Criteria
Inclusion Criteria:
1. 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;
2. 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
3. Co-enrollment in the ATHNdataset.
Exclusion Criteria:
1. Diagnosis of platelet-type VWD;
2. Diagnosis of acquired VWD (clinical diagnosis based on association with hypothyroidism, lymphoproliferative and myeloproliferative disorders, malignancies and cardiovascular disease, typically aortic stenosis or LVAD).
Source: ClinicalTrials.gov (NCT03853486). StuddyBuddy aggregates publicly available trial information.