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NCT06456346Active, not recruitingPhase 3

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 7 May 2026

Brief summary (registry, in English)

1-. To compare bomedemstat to hydroxyurea with respect to DCHR.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
153 (estimated)
First submitted
14 Jun 2024
Start date
15 Nov 2024
Lead sponsor
Merck Sharp & Dohme LLC
EU CT number
2023-505232-36-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 153
  • 49 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Who the study is looking for

  • Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and in 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (49)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ordensklinikum Linz GmbH
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LinzAustriaActive, not recruiting
Universitaetsklinikum Aachen AöR
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AachenGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
Martin-Luther-Universitaet Halle-Wittenberg
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Halle (Saale)GermanyActive, not recruiting
Medizinische Hochschule Hannover
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HanoverGermanyActive, not recruiting
Universitaetsklinikum Jena KöR
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JenaGermanyActive, not recruiting
Dr. Vehling-Kaiser MVZ GmbH
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LandshutGermanyActive, not recruiting
Johannes Gutenberg University Mainz
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MainzGermanyActive, not recruiting
Region Midtjylland
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Aarhus NDenmarkActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Odense University Hospital
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Odense CDenmarkActive, not recruiting
Region Sjaelland
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RoskildeDenmarkActive, not recruiting
Instituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Costa del Sol
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MarbellaSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Hospices Civils De Lyon
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Lyon Cedex 03FranceActive, not recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Hopital Saint Louis
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceActive, not recruiting
University of Debrecen
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DebrecenHungaryActive, not recruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryActive, not recruiting
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryActive, not recruiting
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
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NyíregyházaHungaryActive, not recruiting
University of Szeged
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SzegedHungaryActive, not recruiting
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
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AlexandriaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Careggi University Hospital
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FlorenceItalyActive, not recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyActive, not recruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
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VareseItalyActive, not recruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandActive, not recruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
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KielcePolandActive, not recruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
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LublinPolandActive, not recruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenActive, not recruiting
Karolinska University Hospital
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HuddingeSwedenActive, not recruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenActive, not recruiting
Region Oerebro Laen
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OrebroSwedenActive, not recruiting
Uppsala University Hospital
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UppsalaSwedenActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.