A Study on Estimated Risks of Certain Adverse Events in Adults With Von Willebrand Disease (VWD) Treated With Veyvondi

Takeda

Status: Completed

Conditions: Von Willebrand Disease (VWD)

Study type: Observational

Funder types: Industry

Identifiers

NCT05265078

TAK-577-4005

EUPAS45617 (Registry Identifier)

Details and patient eligibility

About

The main aim of this study is to estimate the risks of certain adverse events in adults with Von Willebrand Disease treated with VEYVONDI. No study medicines will be provided to participants in this study.

Data from medical records of participants diagnosed with Von Willebrand Disease and treated with VEYVONDI will be evaluated during this study.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with 18 years of age or older
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

1. History of any other coagulation or platelet disorder (including acquired VWD).
2. History of neutralizing antibodies / inhibitors to VWF or FVIII.

Trial design

102 participants in 1 patient group

Participants Diagnosed With VWD

Description:

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.