Long-Term Safety and Efficacy Study of Bomedemstat for Participants From Previous Bomedemstat Trials

What this Trial Is About

This research aims to collect long-term safety and efficacy data for participants who have been using bomedemstat and are benefiting from it, or have achieved blood count remission in certain conditions. The study includes individuals with essential thrombocythemia ET, polycythemia vera PV, and myelofibrosis MF who have previously been in earlier bomedemstat trials. It does not involve hypothesis testing but focuses on extended monitoring. Participants will take oral bomedemstat capsules once daily for up to 10 years. The dose they start with will be the same as they used in their previous study before transitioning into this extension. This allows continuous assessment of the effects and safety of the medication over a long period. During the study, participants will be closely monitored for adverse events and any reasons for stopping treatment due to side effects. For those with ET or PV, the duration of their clinical response and remission will be tracked, as well as any progression to more severe conditions. Other outcomes include the frequency of blood clots and bleeding events. Participant involvement may last up to about 10 years, with regular assessments and safety checks throughout.

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)