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

Takeda102 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

102

Conditions

Von Willebrand Disease (VWD)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

MVZ Gerinnungszentrum Hochtaunus

Bad Homburg, Hesse, Germany

Outcomes

Primary Outcomes

Percentage of Participants With Hypersensitivity Reactions

Hypersensitivity reactions are acute events and are considered an adverse events of special interest (AESI) in this study if they occur within 7 days of the infusion (including the day of the initial VEYVONDI infusion).

Time frame: From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years)

Percentage of Participants With Thromboembolic Events

Thrombotic events considered as an AESIs if diagnosed during the 30 days after a VEYVONDI infusion. Thromboembolic events include venous thrombosis, arterial thrombosis, pulmonary embolism, and cerebral artery thrombosis.

Time frame: From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years)

Percentage of Participants With VWF or Factor VIII (FVIII) Inhibitor Formation

Percentage of participants with VWF or FVIII inhibitor formation will be reported.

Time frame: From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years)

Data from ClinicalTrials.gov

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