A Study on Estimated Risks of Certain Adverse Events in Adults With Von Willebrand Disease (VWD) Treated With Veyvondi
NCT ID: NCT05265078
Last Updated: 2023-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
102 participants
OBSERVATIONAL
2022-06-08
2023-04-06
Brief Summary
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Data from medical records of participants diagnosed with Von Willebrand Disease and treated with VEYVONDI will be evaluated during this study.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Participants Diagnosed With VWD
Participants who have been diagnosed with VWD and prescribed VEYVONDI for the approved indications for the index infusion (first eligible VEYVONDI infusion) will be assessed using secondary data obtained from medical records to evaluate the safety of VEYVONDI in real-world clinical practice. All study data will be retrospectively abstracted from medical records by dedicated clinical research staff in partnership with the treating physician. The data window for this study will begin on 01 January 2019 and end one day before site activation at each site.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Participants with diagnosis of congenital VWD.
3. Participants received VEYVONDI with or without a FVIII concentrate.
4. Participants must have at least 7 days of observation time after the index dose.
5. Provides informed consent, if required, in accordance with local ethical and institutional requirements. All medical record data will be abstracted retrospectively; therefore, an exemption or waiver of informed consent will be sought from all associated independent ethics committees (IECs) and institutional review boards (IRBs).
Exclusion Criteria
2. History of neutralizing antibodies / inhibitors to VWF or FVIII.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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MVZ Gerinnungszentrum Hochtaunus
Bad Homburg, Hesse, Germany
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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EUPAS45617
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-577-4005
Identifier Type: -
Identifier Source: org_study_id
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