Bayer AG ((BAYRY)), Bayer Ag (UK) ((GB:0P6S)) announced an update on their ongoing clinical study.
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Study Overview: Bayer AG is conducting an observational study titled ‘Special Drug Use Investigation of Rivaroxaban in Pediatric Patients With Congenital Heart Disease (CHD) Who Had Undergone the Fontan Procedure.’ The study aims to evaluate the safety and efficacy of rivaroxaban, an anticoagulant, in preventing blood clots in children with CHD who have undergone the Fontan procedure. This study is significant as it seeks to provide more data on the drug’s safety, particularly in Japanese patients, where information is currently limited.
Intervention/Treatment: The intervention being tested is rivaroxaban, marketed as Xarelto, which is used to prevent blood clots by inhibiting a specific protein responsible for clotting. It is prescribed to pediatric patients post-Fontan procedure to mitigate the risk of thrombosis.
Study Design: This is a prospective cohort study, meaning researchers will follow a group of children over time to observe outcomes. Data will be collected from regular health visits, and no additional tests or visits are required. The primary focus is on observing major and non-major bleeding events in the participants.
Study Timeline: The study began on June 18, 2024, with data collection running from December 2023 to June 2026. The last update was submitted on June 26, 2025. These dates are crucial as they indicate the study’s progress and timeline for potential results.
Market Implications: The study’s findings could impact Bayer’s stock performance by influencing investor sentiment regarding the safety and efficacy of rivaroxaban in a new patient demographic. Positive results may enhance Bayer’s competitive position in the anticoagulant market, especially against rivals like Pfizer and Bristol-Myers Squibb, who also offer anticoagulant therapies.
The study is ongoing, and further details are available on the ClinicalTrials portal.