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 ‘Observational Study Evaluating Long-term Safety of Real-world Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A.’ The study aims to assess the long-term safety of Jivi, a Factor VIII medication, in patients with hemophilia A. This research is significant as it evaluates the extended use of Jivi, which has a longer half-life, potentially reducing the frequency of injections for patients.
Intervention/Treatment: The study focuses on the drug Damoctocog alfa pegol (Jivi), a recombinant Factor VIII product used as a prophylactic treatment for hemophilia A. Its extended half-life allows it to remain active in the body longer, aiming to decrease the frequency of required injections.
Study Design: This is a prospective observational cohort study. It does not involve random allocation or masking, as it observes patients in real-world settings. The primary purpose is to gather safety data over an extended period.
Study Timeline: The study began on May 14, 2021, and is actively not recruiting. The primary completion and estimated completion dates have not been provided. The latest update was submitted on August 6, 2025, indicating ongoing data collection and analysis.
Market Implications: The ongoing study of Jivi’s long-term safety could positively influence Bayer’s stock performance by reinforcing investor confidence in its hemophilia treatment portfolio. As Jivi offers a competitive edge with its extended half-life, it could strengthen Bayer’s position in the hemophilia treatment market, potentially impacting competitors.
The study is ongoing, with further details available on the ClinicalTrials portal.