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Xarelto Paediatric VTE PASS Drug Utilization Study: An Observational, Longitudinal, Multi-source Drug Utilization Safety Study to Evaluate the Drug Use Patterns and Safety of Rivaroxaban Oral Suspension in Children Under Two Years With Venous Thromboembolism
This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE). VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening. Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information. The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old. The main information that researchers will collect in this study: * Age, gender, and other information about the child and their illness * Type of VTE treatment given to the child * Occurrence of medically important bleeding and its severity Further information that researchers will collect: * Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE * Return of VTE symptoms * Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study. The data for this study will be collected from electronic health records and health insurance claims data until 2026. Researchers will observe each child during treatment until: * end of the anticoagulation treatment period e.g. discontinuation of all study drugs, * their information is no longer available, or * the study ends.
Age
0 - 2 years
Sex
ALL
Healthy Volunteers
No
Many locations
Multiple Locations, Denmark
Many locations
Multiple Locations, France
Many locations
Multiple Locations, Spain
Many locations
Multiple Locations, Sweden
Start Date
September 1, 2026
Primary Completion Date
June 30, 2029
Completion Date
June 30, 2029
Last Updated
March 17, 2026
850
ESTIMATED participants
Rivaroxaban (Xarelto, BAY59-7939)
DRUG
Standard of care (SOC)
DRUG
Lead Sponsor
Bayer
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03728166