Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Launched by MERCK SHARP & DOHME LLC · Jun 7, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called MK-3543-007, is studying a new medication called bomedemstat to see if it works better than hydroxyurea for treating people with a condition called Essential Thrombocythemia (ET). ET is a type of blood disorder where the body makes too many platelets, which can lead to complications like blood clots. The main goal of the trial is to find out if bomedemstat can provide a longer-lasting and better response in managing this condition compared to hydroxyurea.
To be eligible for the trial, participants must have a confirmed diagnosis of Essential Thrombocythemia and be new to treatment (meaning they haven't received any previous therapy for ET). The trial is open to adults aged 65 and older, regardless of gender. Participants will receive either bomedemstat or hydroxyurea and will be monitored for their health and response to the medication. It's important to know that individuals with certain health issues, like serious infections or recent surgeries, won’t be able to participate. This study is currently recruiting participants to help us learn more about the best ways to treat Essential Thrombocythemia.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status
- • Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
- • Has received no prior cytoreductive treatment for their ET
- • Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy
- • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
- • Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable
- Exclusion Criteria:
- • History of any illness/impairment of gastrointestinal function that might interfere with drug absorption
- • History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
- • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- • Has an active infection requiring systemic therapy
- • Has had a major surgery \<4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery \>4 weeks prior to first dose
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Fukuoka, , Japan
Portland, Oregon, United States
Debrecen, , Hungary
Salamanca, , Spain
Kielce, Swietokrzyskie, Poland
Jerusalem, , Israel
Kobe, Hyogo, Japan
Tsu, Mie, Japan
Chuo, Yamanashi, Japan
Miyazaki, , Japan
Tokyo, , Japan
Adelaide, South Australia, Australia
Sapporo, Hokkaido, Japan
Kanazawa, Ishikawa, Japan
Osakasayama, Osaka, Japan
Bunkyo Ku, Tokyo, Japan
Fukushima, , Japan
Hirakata, Osaka, Japan
Okayama, , Japan
Ramat Gan, , Israel
Tainan, , Taiwan
Concepcion, Biobio, Chile
La Serena, Coquimbo, Chile
Santiago, Region M. De Santiago, Chile
Hksar, , Hong Kong
Zerifin, , Israel
Sendai, Miyagi, Japan
Santiago, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Haifa, , Israel
Zerifin, , Israel
Toon, Ehime, Japan
San Miguel De Tucumán, Tucuman, Argentina
La Serena., Coquimbo, Chile
Mainz, Rheinland Pfalz, Germany
Roma, , Italy
Tours, Indre Et Loire, France
Fort Wayne, Indiana, United States
Durham, North Carolina, United States
Abb, Caba, Argentina
Santa Fe, , Argentina
Westmead, New South Wales, Australia
Perth, Western Australia, Australia
Medellín, Antioquia, Colombia
Monteria, Cordoba, Colombia
Bogota, Distrito Capital De Bogota, Colombia
Copenhagen, Hovedstaden, Denmark
Aarhus, Midtjylland, Denmark
Tel Aviv, , Israel
Toyoake, Aichi, Japan
Katowice, Slaskie, Poland
Barcelona, Cataluna, Spain
Madrid, Madrid, Comunidad De, Spain
Madrid, Madrid, Comunidad De, Spain
Marbella, Malaga, Spain
Madrid, , Spain
Chiayi City, Chiayi, Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Linz, Oberosterreich, Austria
Odense C, Syddanmark, Denmark
Pessac, Aquitaine, France
Firenze, Toscana, Italy
Bologna, , Italy
Santander, Cantabria, Spain
Lund, Skane Lan, Sweden
Huddinge, Stockholms Lan, Sweden
Pilar, Buenos Aires, Argentina
Santiago, Region M. De Santiago, Chile
Landshut, Bayern, Germany
Aachen, Nordrhein Westfalen, Germany
Essen, Nordrhein Westfalen, Germany
Halle, Sachsen Anhalt, Germany
Gyor, Gyor Moson Sopron, Hungary
Kaposvár, Somogy, Hungary
Haifa, , Israel
Petah Tikva, , Israel
Milano, Lombardia, Italy
Alessandria, , Italy
Pavia, , Italy
Barcelona, , Spain
Uppsala, Uppsala Lan, Sweden
Gothenburg, Vastra Gotalands Lan, Sweden
Lublin, Lubelskie, Poland
Charlottesville, Virginia, United States
Heidelberg, Victoria, Australia
Nice, Alpes Maritimes, France
Marseille, Bouches Du Rhone, France
Toulouse, Haute Garonne, France
Nantes, Loire Atlantique, France
Paris, , France
Jena, Thuringen, Germany
Nyiregyhaza, Szabolcs Szatmar Bereg, Hungary
Varese, , Italy
Toyoake, Aichi, Japan
Osakasayama, Osaka, Japan
Fukushima, , Japan
Chihuahua City, Chihuahua, Mexico
Mexico City, Distrito Federal, Mexico
Oaxaca De Juarez, Oaxaca, Mexico
Badalona, Barcelona, Spain
Clayton, Victoria, Australia
Oaxaca De Juarez., Oaxaca, Mexico
örebro, Orebro Lan, Sweden
Westmead, New South Wales, Australia
Roskilde, Sjaelland, Denmark
Golden, Colorado, United States
Limoges, Haute Vienne, France
Be'er Sheva, , Israel
Palo Alto, California, United States
Richmond, Virginia, United States
Monteria, Cordoba, Colombia
Pierre Bénite, Rhone, France
Creteil, Val De Marne, France
Alessandria, Ancona, Italy
L'hospitalet De Llobregat, Cataluna, Spain
Bodelwyddan, Denbighshire, United Kingdom
Gwent, Newport, United Kingdom
Glendale, California, United States
San Antonio, Texas, United States
La Serena., Coquimbo, Chile
London, London, City Of, United Kingdom
Tours, Indre Et Loire, France
Hannover, Niedersachsen, Germany
Mainz, Rheinland Pfalz, Germany
Jena, Thuringen, Germany
Szeged, Csongrad, Hungary
Roma, , Italy
Lublin, Lubelskie, Poland
Kielce, Swietokrzyskie, Poland
Salamanca, , Spain
Berlin, , Germany
Gloucester, Gloucestershire, United Kingdom
Hannover, Niedersachsen, Germany
Lincoln, Great Britain, United Kingdom
Boston, , United Kingdom
Newport, , United Kingdom
Greenfield Park, Quebec, Canada
Madrid, , Spain
Madrid, , Spain
Boston, Lincolnshire, United Kingdom
London, , United Kingdom
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported