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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Von Willebrand Disease (VWD) Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders von Willebrand Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MVZ Gerinnungszentrum Hochtaunus

Bad Homburg, Hesse, 61352, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Percentage of Participants With Hypersensitivity Reactions

Time frame: 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

Time frame: 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

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 FVIII inhibitor formation will be reported.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Estimating Risk of Selected Adverse Events in Patients With Von Willebrand Disease Treated With VEYVONDI® (Vonicog Alfa; Recombinant Von Willebrand Factor)

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Mar 3, 2022
Registry last updated: Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed