A Study on Estimated Risks of Certain Adverse Events in Adults With Von Willebrand Disease (VWD) Treated With Veyvondi
Estimating Risk of Selected Adverse Events in Patients With Von Willebrand Disease Treated With VEYVONDI® (Vonicog Alfa; Recombinant Von Willebrand Factor)
2 other identifiers
observational
102
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2022
CompletedFirst Posted
Study publicly available on registry
March 3, 2022
CompletedStudy Start
First participant enrolled
June 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2023
CompletedAugust 31, 2023
August 1, 2023
10 months
March 2, 2022
August 30, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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).
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.
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.
From 01 January 2019 up to one day before site activation at each site (up to approximately 4 years)
Study Arms (1)
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.
Eligibility Criteria
Participants who have been diagnosed with VWD and were prescribed VEYVONDI in Europe.
You may qualify if:
- Participants with 18 years of age or older
- Participants with diagnosis of congenital VWD.
- Participants received VEYVONDI with or without a FVIII concentrate.
- Participants must have at least 7 days of observation time after the index dose.
- 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).
You may not qualify if:
- History of any other coagulation or platelet disorder (including acquired VWD).
- History of neutralizing antibodies / inhibitors to VWF or FVIII.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
MVZ Gerinnungszentrum Hochtaunus
Bad Homburg, Hesse, 61352, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2022
First Posted
March 3, 2022
Study Start
June 8, 2022
Primary Completion
April 6, 2023
Study Completion
April 6, 2023
Last Updated
August 31, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.