A Study on Estimated Risks of Certain Adverse Events in Adults With Von Willebrand Disease (VWD) Treated With Veyvondi
- Conditions
- Von Willebrand Disease (VWD)
- Registration Number
- NCT05265078
- Lead Sponsor
- Takeda
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Hypersensitivity Reactions From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years) 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).
Percentage of Participants With Thromboembolic Events From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years) 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.
Percentage of Participants With VWF or Factor VIII (FVIII) Inhibitor Formation 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 FVIII inhibitor formation will be reported.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MVZ Gerinnungszentrum Hochtaunus
🇩🇪Bad Homburg vor der Höhe, Hessen, Germany