clinical trial · NCT06456346
Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Merck Sharp & Dohme LLC·phase3·recruiting·n = 300
Essential ThrombocythemiaBomedemstatHydroxyureaBomedemstat placeboHydroxyurea placebo
brief summary
The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.
started
Jul 16, 2024
primary completion
Sep 28, 2027
completion
Mar 24, 2028
last updated
May 15, 2026
official title
A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK-3543) Versus Hydroxyurea in Cytoreductive Therapy Naïve Essential Thrombocythemia Participants
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol