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
- Diseases
- Myeloproliferative neoplasms
- 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
Sites (49)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Active, not recruiting |
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Active, not recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Martin-Luther-Universitaet Halle-Wittenberg Coordinator of this site? Confirm its status | Halle (Saale) | Germany | Active, not recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Active, not recruiting |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Active, not recruiting |
| Dr. Vehling-Kaiser MVZ GmbH Coordinator of this site? Confirm its status | Landshut | Germany | Active, not recruiting |
| Johannes Gutenberg University Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Active, not recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Active, not recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Active, not recruiting |
| Region Sjaelland Coordinator of this site? Confirm its status | Roskilde | Denmark | Active, not recruiting |
| Instituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Costa del Sol Coordinator of this site? Confirm its status | Marbella | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| Hospices Civils De Lyon Coordinator of this site? Confirm its status | Lyon Cedex 03 | France | Active, not recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Active, not recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Active, not recruiting |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Active, not recruiting |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Active, not recruiting |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Active, not recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo Coordinator of this site? Confirm its status | Alexandria | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi Coordinator of this site? Confirm its status | Varese | Italy | Active, not recruiting |
| Pratia Hematologia Sp. Z o. o Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach Coordinator of this site? Confirm its status | Kielce | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Active, not recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Huddinge | Sweden | Active, not recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Active, not recruiting |
| Region Oerebro Laen Coordinator of this site? Confirm its status | Orebro | Sweden | Active, not recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.