During this reporting period, significant progress was made in completing the study and preparing for its official close. The final monitoring visit took place in December 2024, ensuring that all data was thoroughly verified, and the study team completed the final steps needed to lock the study database. This included reviewing and signing off on over 5,000 electronic case report forms (eCRFs).
In January 2025, the study team conducted a close-out visit, providing all necessary regulatory documents and final reports to the Institutional Review Board (IRB), which officially closed the study at the end of the month. Data from the study was then analyzed for key safety and efficacy results, contributing to a comprehensive Clinical Study Report (CSR) that was finalized in early February 2025.
With these milestones achieved, the study has successfully met its objectives and requirements, marking an important step in advancing research for the treatment of Cystinosis.