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A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)

NCT05900388 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 850

Last updated 2026-05-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Retrospective cohort analysis using National health registers in Denmark and Sweden; Système National Des Données De Santé (SNDS) in France and Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària (SIDIAP) in Spain

DRUG

Standard of care (SOC)

Retrospective cohort analysis using National health registers in Denmark and Sweden; Système National Des Données De Santé (SNDS) in France and Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària (SIDIAP) in Spain. SOC including heparins, Vitamin K antagonists (VKAs) and Other Direct oral anticoagulants (DOACs).

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • Denmark
  • France
  • Spain
  • Sweden

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05900388 on ClinicalTrials.gov