Last updated 24 days ago

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

300 patients around the world
Available in Chile, Argentina
Merck Sharp & Dohme LLC
9Research sites
300Patients around the world

This study is for people with

Myeloproliferative syndromes
Essential thrombocythemia

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and in indication for cytoreductive therapy.
Has a 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.
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.

Sites

Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH
Sanatorio 9 de Julio - Tucumán
Sanatorio 9 de Julio - Tucumán
Recruiting
San Juan 537, San Miguel de Tucumán, CP 4000
Clínica de Nefrología Urología y Enfermedades Cardiovasculares - Santa Fe
Recruiting
Av. Freyre 3074, Santa Fe
Hospital Universitario Austral - Pilar
Recruiting
Av. Juan Domingo Perón 1500, Pilar, Buenos Aires
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
Manzano 343, Recoleta, Región Metropolitana, Santiago
Biocenter
Recruiting
Concepción, Biobio 4070196
Clínica Alemana
Recruiting
Av. Vitacura 5951, Vitacura, Región Metropolitana, Santiago
Inmunocel
Recruiting
Av. Pdte. Kennedy 5488, 7630716 Vitacura, Región Metropolitana, Chile
IC La Serena Research - La Serena
Recruiting
Woodrow Wilson 1697, La Serena, Chile
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