Bayer AG ((BAYRY)) announced an update on their ongoing clinical study.
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Bayer AG, in collaboration with Janssen Research & Development, LLC, has initiated a study titled ‘Xarelto Paediatric VTE PASS Drug Utilization Study’ to observe the use and safety of Rivaroxaban in children under two years old with venous thromboembolism (VTE). This study aims to gather crucial data on the drug’s usage patterns and safety profile in this young demographic, where current information is limited.
The study focuses on Rivaroxaban, an oral suspension drug, and its comparison with the standard of care (SOC) treatments, which include heparins, Vitamin K antagonists, and other direct oral anticoagulants. The primary goal is to evaluate how these treatments are used and their safety in treating VTE in young children.
This observational study employs a cohort model with a retrospective time perspective, utilizing data from electronic health records and health insurance claims. It will track children under two years receiving Rivaroxaban or SOC for VTE, collecting data on demographics, treatment types, and any significant bleeding events.
The study began on May 10, 2023, with the last update submitted on October 20, 2025. It is expected to continue collecting data until 2026, providing a comprehensive overview of treatment patterns and safety outcomes.
The study’s findings could significantly impact Bayer’s market position, potentially enhancing investor confidence if Rivaroxaban proves effective and safe. This could also influence the competitive landscape, as other companies in the anticoagulant market may need to reassess their strategies.
The study is ongoing, with further details available on the ClinicalTrials portal.