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
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
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.
Inclusion Criteria:
Exclusion Criteria:
Fort Wayne, Indiana 46845, United States
Winston-Salem, North Carolina 27157, United States
Eugene, Oregon 97401, United States
San Antonio, Texas 78229, United States
ABB, Buenos Aires F.D. C1199ABB, Argentina
Santa Fe, 3000, Argentina
Adelaide, South Australia 5000, Australia
Greenfield Park, Quebec J4V 2H1, Canada
Beijing, Beijing Municipality 100730, China
Quanzhou, Fujian 362000, China
Guangzhou, Guangdong 510120, China
Guangzhou, Guangdong 510515, China
Shijiazhuang, Hebei 050000, China
Wuhan, Hubei 430022, China
Nanchang, Jiangxi 330209, China
Shanghai, Shanghai Municipality 200032, China
Tianjin, Tianjin Municipality 301636, China
Hangzhou, Zhejiang 310000, China
Yiwu, Zhejiang 322000, China
Odense C, Region Syddanmark 5000, Denmark
Nice, Alpes-Maritimes 06202, France
Pessac, Aquitaine 33600, France
Toulouse, Haute-Garonne 31059, France
Limoges, Haute-Vienne 87042, France
Tours, Indre-et-Loire 37000, France
Nantes, Pays de la Loire Region 44093, France
Mainz, Rhineland-Palatinate 55131, Germany
Jena, Thuringia 07747, Germany
Hksar, Hong Kong
Szeged, Csongrád megye 6725, Hungary
Kaposvár, Somogy County 7400, Hungary
Nyíregyháza, Szabolcs-Szatmár-Bereg 4400, Hungary
Debrecen, 4032, Hungary
Alessandria, 15121, Italy
Bologna, 40138, Italy
Roma, 00168, Italy
Bunkyo-ku, Tokyo 113-8431, Japan
Lublin, Lublin Voivodeship 20-081, Poland
Kielce, Świętokrzyskie Voivodeship 25-734, Poland
Badalona, Barcelona 08916, Spain
L'Hospitalet de Llobregat, Barcelona 08908, Spain
Santander, Cantabria 39008, Spain
Madrid, Madrid, Comunidad de 28027, Spain
Madrid, Madrid, Comunidad de 28034, Spain
Barcelona, 08035, Spain
Salamanca, 37007, Spain
Lund, Skåne County 22185, Sweden
Gothenburg, Västra Götaland County 413 45, Sweden
Ankara, 06200, Turkey (Türkiye)
Ankara, 06230, Turkey (Türkiye)