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

Not yet recruitingOBSERVATIONAL
Enrollment

850

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

June 30, 2029

Study Completion Date

June 30, 2029

Conditions
Venous ThromboembolismChildren Under 2 Years
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).

Trial Locations (4)

Unknown

Many locations, Multiple Locations

Many locations, Multiple Locations

Many locations, Multiple Locations

Many locations, Multiple Locations

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Bayer

INDUSTRY