Active — Not RecruitingNot Applicable

ATHN 9: Severe VWD Natural History Study

United States108 participantsStarted 2019-06-18

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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).

What they're measuring

Reported adverse events from VWF regimens for different indications (on-demand, surgery, and prophylaxis) as measured by EUHASS.

Timeframe: 2 years

Trial details

NCT IDNCT03853486

SponsorAmerican Thrombosis and Hemostasis Network

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Von Willebrand Diseases trials