Bomedemstat vs Hydroxyurea for essentiel trombocytæmi (MK-3543-007)
24. august 2026 opdateret af: Merck Sharp & Dohme LLC
En fase 3, randomiseret, dobbeltblind, aktiv-komparator-kontrolleret klinisk undersøgelse for at evaluere effektiviteten og sikkerheden af Bomedemstat (MK-3543) versus Hydroxyurea i cytoreduktiv terapi Naive essentielle trombocytæmi-deltagere
Formålet med denne undersøgelse er at evaluere effektiviteten og sikkerheden af bomedemstat sammenlignet med hydroxyurinstof i cytoreduktiv terapi naive essentiel trombocytæmi (ET) deltagere, for hvem cytoreduktiv terapi er indiceret.
Dets primære mål er at sammenligne bomedemstat med hydroxyurinstof med hensyn til varig klinisk hæmatologisk respons (DCHR).
Den primære hypotese er, at bomedemstat er bedre end hydroxyurinstof med hensyn til DCHR.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
300
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Santa Fe, Argentina, 3000
- Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0105)
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Buenos Aires
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Pilar, Buenos Aires, Argentina, B1629AHJ
- Hospital Universitario Austral ( Site 0101)
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Buenos Aires F.D.
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ABB, Buenos Aires F.D., Argentina, C1199ABB
- Hospital Italiano de Buenos Aires ( Site 0102)
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000IKO
- C.I.C.E. 9 de Julio ( Site 0104)
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New South Wales
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Westmead, New South Wales, Australien, 2115
- Westmead Hospital ( Site 0201)
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South Australia
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Adelaide, South Australia, Australien, 5000
- Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0203)
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Victoria
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Clayton, Victoria, Australien, 3168
- Monash Health-Haematology Research ( Site 0202)
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Heidelberg, Victoria, Australien, 3084
- Austin Health-Cancer Clinical Trials Centre ( Site 0206)
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Western Australia
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Perth, Western Australia, Australien, 6000
- Royal Perth Hospital-Haematology ( Site 0204)
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
- Arthur J.E. Child Comprehensive Cancer Centre ( Site 0038)
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
- Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0037)
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Biobio
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Concepción, Biobio, Chile, 4070196
- Biocenter ( Site 0149)
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Coquimbo Region
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La Serena, Coquimbo Region, Chile, 1720430
- IC La Serena Research ( Site 0150)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7500921
- FALP-UIDO ( Site 0148)
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Santiago, Region M. de Santiago, Chile, 7580206
- Clínica Inmunocel ( Site 0147)
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Santiago, Region M. de Santiago, Chile, 7650568
- Clínica Alemana de Santiago ( Site 0143)
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Santiago, Region M. de Santiago, Chile, 8420383
- Bradfordhill-Clinical Area ( Site 0142)
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Antioquia
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Medellín, Antioquia, Colombia, 050030
- Fundacion Colombiana de Cancerología Clinica Vida ( Site 0164)
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 110121
- Los Cobos Medical Center ( Site 0165)
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Departamento de Córdoba
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Montería, Departamento de Córdoba, Colombia, 230002
- IMAT S.A.S ( Site 0162)
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Capital Region
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Copenhagen, Capital Region, Danmark, 2100
- Rigshospitalet-Hematology - CTU ( Site 0321)
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Central Jutland
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Aarhus, Central Jutland, Danmark, 8200
- Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0324)
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Region Sjælland
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Roskilde, Region Sjælland, Danmark, 4000
- Roskilde Sygehus-Department of Hematology ( Site 0323)
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Region Syddanmark
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Odense C, Region Syddanmark, Danmark, 5000
- Odense Universitetshospital-Department of Hematology ( Site 0325)
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Newcastle upon Tyne, Det Forenede Kongerige, NE7 7DN
- Freeman Hospital ( Site 0532)
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Newport, Det Forenede Kongerige, NP20 2EF
- Royal Gwent Hospital ( Site 0524)
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Denbighshire
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Bodelwyddan, Denbighshire, Det Forenede Kongerige, LL18 5UJ
- Glan Clwyd Hospital ( Site 0528)
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Gloucestershire
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Gloucester, Gloucestershire, Det Forenede Kongerige, Gl1 3NN
- Gloucestershire Royal Hospital ( Site 0521)
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Great Britain
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Lincoln, Great Britain, Det Forenede Kongerige, LN2 5QY
- Lincoln County Hospital ( Site 0535)
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Lincolnshire
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Boston, Lincolnshire, Det Forenede Kongerige, PE21 9QS
- Boston Pilgrim Hospital ( Site 0525)
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London, City of
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London, London, City of, Det Forenede Kongerige, NW1 2PG
- University College London Hospital ( Site 0527)
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London, London, City of, Det Forenede Kongerige, SE1 9RT
- Guy's & St Thomas' NHS Foundation Trust ( Site 0523)
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London, London, City of, Det Forenede Kongerige, W12 OHS
- Hammersmith Hospital ( Site 0533)
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Arizona
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Glendale, Arizona, Forenede Stater, 85304
- Palo Verde Cancer Specialists ( Site 0052)
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California
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Glendale, California, Forenede Stater, 91206
- Los Angeles Cancer Network ( Site 0025)
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Palo Alto, California, Forenede Stater, 94304
- Stanford Cancer Center ( Site 0024)
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Colorado
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Golden, Colorado, Forenede Stater, 80401
- Exempla Lutheran Medical Center ( Site 0014)
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Yale University School of Medicine ( Site 0051)
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46845
- Parkview Research Center at Parkview Regional Medical Center ( Site 0006)
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan ( Site 0003)
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89102
- Optum Care Cancer Center ( Site 0053)
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204
- Levine Cancer Institute ( Site 0009)
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Health System (DUHS) ( Site 0012)
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013)
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Ohio
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Columbus, Ohio, Forenede Stater, 43210
- The Ohio State University Wexner Medical Center ( Site 0028)
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
- Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8005)
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health & Science University ( Site 0018)
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- TriStar Bone Marrow ( Site 7000)
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Texas
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Amarillo, Texas, Forenede Stater, 79124
- Texas Oncology - West Texas ( Site 8003)
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Dallas, Texas, Forenede Stater, 75246
- Texas Oncology - DFW ( Site 8006)
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Houston, Texas, Forenede Stater, 77030
- University of Texas MD Anderson Cancer Center ( Site 0026)
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San Antonio, Texas, Forenede Stater, 78229
- University of Texas Health Science Center at San Antonio ( Site 0021)
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Webster, Texas, Forenede Stater, 77598
- Texas Oncology - Gulf Coast ( Site 8008)
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia ( Site 0020)
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Richmond, Virginia, Forenede Stater, 23219
- VCU Health Adult Outpatient Pavillion ( Site 0008)
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Paris, Frankrig, 75010
- Hopital Saint-Louis ( Site 0341)
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Frankrig, 06202
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Hematology ( Site 0349)
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Aquitaine
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Pessac, Aquitaine, Frankrig, 33600
- CHU Bordeaux Haut-Leveque-service de mèdecine interne et maladies infectieuses ( Site 0346)
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Bouches-du-Rhone
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Marseille, Bouches-du-Rhone, Frankrig, 13005
- Hôpital de la Conception ( Site 0351)
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrig, 31059
- Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0352)
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Haute-Vienne
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Limoges, Haute-Vienne, Frankrig, 87042
- Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0344)
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Indre-et-Loire
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Tours, Indre-et-Loire, Frankrig, 37000
- Centre Hospitalier Régional Universitaire de Tours - Hôpital-Hématologie et Thérapie Cellulaire ( Site 0342)
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Pays de la Loire Region
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Nantes, Pays de la Loire Region, Frankrig, 44093
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0347)
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Rhone
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Pierre-Bénite, Rhone, Frankrig, 69310
- centre hospitalier lyon sud ( Site 0343)
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Val-de-Marne
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Créteil, Val-de-Marne, Frankrig, 94010
- HENRI MONDOR HOSPITAL ( Site 0348)
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Hksar, Hong Kong
- Queen Mary Hospital ( Site 0221)
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Beersheba, Israel, 8410101
- Soroka Medical Center ( Site 0427)
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Haifa, Israel, 3109601
- Rambam Health Care Campus ( Site 0429)
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Haifa, Israel, 3436212
- Carmel Hospital ( Site 0426)
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Jerusalem, Israel, 9112001
- Hadassah Medical Center ( Site 0424)
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Nahariya, Israel, 2201202
- Galilee Medical Center ( Site 0431)
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Petah Tikva, Israel, 4941492
- Rabin Medical Center ( Site 0425)
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Ramat Gan, Israel, 5265601
- Sheba Medical Center ( Site 0428)
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Tel Aviv, Israel, 6423906
- Sourasky Medical Center ( Site 0422)
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Ẕerifin, Israel, 7033001
- Yitzhak Shamir Medical Center. ( Site 0421)
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Alessandria, Italien, 15121
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0443)
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Bologna, Italien, 40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0446)
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Milan, Italien, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0447)
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Pavia, Italien, 27100
- Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0444)
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Roma, Italien, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0445)
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Varese, Italien, 21100
- Ospedale di Circolo e Fondazione Macchi Varese ( Site 0442)
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Tuscany
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Florence, Tuscany, Italien, 50134
- Azienda Ospedaliera Universitaria Careggi ( Site 0441)
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Fukuoka, Japan, 812-8582
- Kyushu University Hospital ( Site 0605)
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Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital ( Site 0616)
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Miyazaki, Japan, 889-1692
- University of Miyazaki Hospital ( Site 0609)
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Okayama, Japan, 700-8558
- Okayama University Hospital ( Site 0604)
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Tokyo, Japan, 113-8603
- Nippon Medical School Hospital ( Site 0608)
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Aichi-ken
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Toyoake, Aichi-ken, Japan, 470-1192
- Fujita Health University Hospital ( Site 0613)
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Ehime
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Tōon, Ehime, Japan, 791-0295
- Ehime University Hospital ( Site 0612)
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8648
- Hokkaido University Hospital ( Site 0601)
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Hyōgo
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Kobe, Hyōgo, Japan, 650-0047
- Kobe City Medical Center General Hospital ( Site 0603)
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japan, 920-8641
- Kanazawa University Hospital ( Site 0614)
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Mie-ken
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Tsu, Mie-ken, Japan, 514-8507
- Mie University Hospital ( Site 0615)
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Miyagi
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Sendai, Miyagi, Japan, 983-8520
- National Hospital Organization Sendai Medical Center ( Site 0617)
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Osaka
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Hirakata, Osaka, Japan, 573-1191
- Kansai Medical University Hospital ( Site 0607)
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Sakai, Osaka, Japan, 590-0197
- Kindai University Hospital ( Site 0600)
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital ( Site 0611)
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Yamanashi
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Chūō, Yamanashi, Japan, 409-3898
- University of Yamanashi Hospital ( Site 0606)
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Anhui
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Bengbu, Anhui, Kina, 233004
- The First Afflilated Hospital of Bengbu Medical College ( Site 0651)
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Hefei, Anhui, Kina, 230001
- Anhui Provincial Hospital ( Site 0657)
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100191
- Peking University Third Hospital-Hematology ( Site 0659)
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Beijing, Beijing Municipality, Kina, 100730
- Chinese Academy of medical science, Peking Union Medical College Hospital(Dongdan) ( Site 0675)
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400030
- Chongqing University Cancer Hospital ( Site 0666)
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Fujian
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Quanzhou, Fujian, Kina, 362000
- The Second Affiliated Hospital of Fujian Medical University ( Site 0671)
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Xiamen, Fujian, Kina, 361003
- The First Affiliated hospital of Xiamen University ( Site 0658)
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Guangdong
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Guangzhou, Guangdong, Kina, 510120
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University-hematology department ( Site 0668)
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Guangzhou, Guangdong, Kina, 510515
- Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 0655)
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Hebei
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Shijiazhuang, Hebei, Kina, 050000
- The Second Afilliated Hospital of Hebei Medical University ( Site 0650)
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Shijiazhuang, Hebei, Kina, 050031
- The First Hospital of Hebei Medical University ( Site 0649)
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Henan
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Zhengzhou, Henan, Kina, 450008
- Henan Cancer Hospital-hematology department ( Site 0644)
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Hubei
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Wuhan, Hubei, Kina, 430022
- Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0642)
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Jiangsu
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Suzhou, Jiangsu, Kina, 215006
- The First Affiliated Hospital of Soochow University ( Site 0676)
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Jiangxi
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Nanchang, Jiangxi, Kina, 330209
- The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0645)
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Jilin
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Changchun, Jilin, Kina, 130021
- The First Hospital of Jilin University-Hematology ( Site 0672)
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Shaanxi
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Xi'an, Shaanxi, Kina, 710068
- Shaanxi provincial people's hospital ( Site 0652)
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Shandong
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Jinan, Shandong, Kina, 250013
- Jinan Central Hospital ( Site 0667)
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200032
- Zhongshan Hospital,Fudan University-Hematology ( Site 0674)
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Shanghai, Shanghai Municipality, Kina, 200040
- Huashan Hospital, Fudan University ( Site 0669)
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- West China Hospital, Sichuan University ( Site 0661)
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 301636
- Institute of hematology&blood disease hospital-Hematology ( Site 0641)
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310000
- The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 0646)
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Yiwu, Zhejiang, Kina, 322000
- Zhejiang University School of Medicine-The Fourth Affiliated Hospital ( Site 0662)
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Chihuahua
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Chihuahua City, Chihuahua, Mexico, 31203
- Medivest Centro de Investigación Integral ( Site 0183)
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Mexico City
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Mexico City, Mexico City, Mexico, 11819
- Higiea Oncologia ( Site 0184)
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Oaxaca
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Oaxaca City, Oaxaca, Mexico, 68020
- Centro de Investigacion Clinica de Oaxaca ( Site 0181)
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polen, 20-081
- Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii, Transplantacji Szp ( Site 0463)
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Polen, 40-519
- Pratia Onkologia Katowice ( Site 0461)
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Świętokrzyskie Voivodeship
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Kielce, Świętokrzyskie Voivodeship, Polen, 25-734
- Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S ( Site 0466)
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Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0489)
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Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre ( Site 0494)
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Salamanca, Spanien, 37007
- Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( Site 0488)
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Barcelona
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Badalona, Barcelona, Spanien, 08916
- Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0490)
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L'Hospitalet de Llobregat, Barcelona, Spanien, 08908
- Institut Català d'Oncologia - L'Hospitalet ( Site 0482)
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Cantabria
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Santander, Cantabria, Spanien, 39008
- Hospital Universitario Marqués de Valdecilla-Haematology ( Site 0486)
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Catalonia
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Barcelona, Catalonia, Spanien, 08036
- HOSPITAL CLÍNIC DE BARCELONA ( Site 0481)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spanien, 28027
- Clinica Universidad de Navarra-Hematology Department ( Site 0485)
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Madrid, Madrid, Comunidad de, Spanien, 28034
- Hospital Universitario Ramón y Cajal-Hematology ( Site 0484)
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Malaga
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Marbella, Malaga, Spanien, 29603
- Hospital Costa del Sol-Hematology Service ( Site 0493)
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-
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Skåne County
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Lund, Skåne County, Sverige, 22185
- Skånes Universitetssjukhus Lund-Department of Hematology ( Site 0544)
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Stockholm County
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Huddinge, Stockholm County, Sverige, 141 86
- Karolinska Universitetssjukhuset Huddinge ( Site 0541)
-
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Uppsala County
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Uppsala, Uppsala County, Sverige, 751 85
- Akademiska sjukhuset ( Site 0545)
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Västra Götaland County
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Gothenburg, Västra Götaland County, Sverige, 413 45
- Sahlgrenska Universitetssjukhuset-Department of hematology and coagulation ( Site 0543)
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Örebro County
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Örebro, Örebro County, Sverige, 701 85
- Universitetssjukhuset Örebro ( Site 0542)
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-
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital-Clinical Trial Center ( Site 0245)
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Taipei, Taiwan, 10002
- National Taiwan University Hospital ( Site 0241)
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Taoyuan, Taiwan, 33305
- Chang Gung Medical Foundation-Linkou Branch ( Site 0243)
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Chiayi
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Chiayi City, Chiayi, Taiwan, 613
- Chang Gung Memorial Hospital- Chiayi ( Site 0242)
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-
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Ankara, Tyrkiet (Türkiye), 06200
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-Hemotology ( Site 0510)
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Ankara, Tyrkiet (Türkiye), 06230
- Hacettepe Universite Hastaneleri-Department of Hematology ( Site 0505)
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Ankara, Tyrkiet (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0502)
-
Ankara, Tyrkiet (Türkiye), 6620
- Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 0511)
-
Antalya, Tyrkiet (Türkiye), 07100
- Antalya Egitim ve Arastırma Hastanesi ( Site 0508)
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Edirne, Tyrkiet (Türkiye), 22030
- Trakya University Medical Faculty Hospital-Hematology ( Site 0501)
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Istanbul, Tyrkiet (Türkiye), 34214
- Medipol Mega Universite Hastanesi ( Site 0504)
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Kocaeli, Tyrkiet (Türkiye), 41380
- Kocaeli Üniversitesi-Hematology ( Site 0506)
-
Samsun, Tyrkiet (Türkiye), 55139
- Ondokuz Mayıs Universitesi-hematology ( Site 0507)
-
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İzmir
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Bornova, İzmir, Tyrkiet (Türkiye), 35100
- Ege Universitesi Hastanesi ( Site 0503)
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-
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Berlin, Tyskland, 13353
- Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0369)
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Bavaria
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Landshut, Bavaria, Tyskland, 84036
- VK&K Studien GbR ( Site 0370)
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Lower Saxony
-
Hanover, Lower Saxony, Tyskland, 30625
- Medizinische Hochschule Hannover ( Site 0371)
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North Rhine-Westphalia
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Aachen, North Rhine-Westphalia, Tyskland, 52074
- Universitätsklinikum Aachen ( Site 0367)
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Essen, North Rhine-Westphalia, Tyskland, 45147
- Universitaetsklinikum Essen ( Site 0366)
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Tyskland, 55131
- Universitätsmedizin Johannes Gutenberg Universität Mainz-3. Medizinische Klinik und Poliklinik ( Site 0365)
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Saxony-Anhalt
-
Halle, Saxony-Anhalt, Tyskland, 06120
- Universitätsklinikum Halle ( Site 0361)
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Thuringia
-
Jena, Thuringia, Tyskland, 07747
- Universitätsklinikum Jena-Klinik für Innere Medizin II, Abt. Hämatologie und Internistische Onkolog ( Site 0364)
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-
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Debrecen, Ungarn, 4032
- Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)
-
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Csongrád megye
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Szeged, Csongrád megye, Ungarn, 6725
- Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 0407)
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Győr-Moson-Sopron
-
Győr, Győr-Moson-Sopron, Ungarn, 9024
- Petz Aladar Egyetemi Oktato Korhaz-Hematológia ( Site 0405)
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Somogy County
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Kaposvár, Somogy County, Ungarn, 7400
- Somogy Vármegyei Kaposi Mór Oktató Kórház-Haematológiai osztály ( Site 0406)
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Szabolcs-Szatmár-Bereg
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Nyíregyháza, Szabolcs-Szatmár-Bereg, Ungarn, 4400
- Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór-Haematológia osztály ( Site 0404)
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Upper Austria
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Linz, Upper Austria, Østrig, 4020
- Ordensklinikum Linz GmbH Elisabethinen ( Site 0562)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Diagnose af essentiel trombocytæmi (ET) baseret på Verdenssundhedsorganisationens kriterier for myeloproliferative neoplasmer og som indikation for cytoreduktiv terapi
- Har en knoglemarvsfibrose-score på grad 0 eller grad 1 i henhold til en ændret version af de europæiske konsensuskriterier for graduering af myelofibrose
- Har ikke modtaget tidligere cytoreduktiv behandling for deres ET
- Human Immundefekt Virus (HIV)-inficerede deltagere har velkontrolleret HIV på antiretroviral terapi
- Deltagere, der er hepatitis B overfladeantigen (HBsAg) positive, er kvalificerede, hvis de har modtaget hepatitis B virus (HBV) antiviral behandling i mindst 4 uger og har en upåviselig HBV viral belastning
- Deltagere med en historie med hepatitis C-virus (HCV)-infektion er kvalificerede, hvis HCV-virusmængden ikke kan påvises
Ekskluderingskriterier:
- Anamnese med enhver sygdom/svækkelse af mave-tarmfunktionen, der kan interferere med lægemiddelabsorptionen
- Anamnese med en malignitet, medmindre potentielt helbredende behandling er afsluttet uden tegn på malignitet i 2 år
- HIV-inficerede deltagere med en historie med Kaposis sarkom og/eller multicentrisk Castlemans sygdom
- Har en aktiv infektion, der kræver systemisk terapi
- Har haft en større operation <4 uger før første dosis af undersøgelsesintervention eller er ikke kommet sig over bivirkninger fra større operation >4 uger før første dosis
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Bomedemstat
Deltagerne vil modtage aktiv bomedemstat og hydroxyurinstof placebo dagligt i op til cirka 52 uger.
Dosis vil blive justeret enten op eller ned inden for specificerede tidsparametre for hver deltager til den dosis, der giver tilstrækkelig eksponering til sikkert at hæmme trombopoiese for at reducere trombocyttallet til målområdet.
Deltagere, der afslutter behandlingen i uge 52, vil være berettiget til at fortsætte behandlingen i den udvidede behandlingsfase.
Afblænding vil forekomme, og placebo seponeres, når alle deltagere har afsluttet mindst 52 ugers behandling eller på anden måde afbrudt.
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Oral kapsel
Andre navne:
Oral kapsel placebo
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Aktiv komparator: Hydroxyurinstof
Deltagerne vil modtage aktivt hydroxyurinstof og bomedemstat placebo dagligt i op til 52 uger.
Dosis vil blive justeret enten op eller ned inden for specificerede tidsparametre for hver deltager til den dosis, der giver tilstrækkelig eksponering til sikkert at hæmme trombopoiese for at reducere trombocyttallet til målområdet.
Deltagere, der afslutter behandlingen i uge 52, vil være berettiget til at fortsætte behandlingen i den udvidede behandlingsfase.
Afblænding vil forekomme, og placebo seponeres, når alle deltagere har afsluttet mindst 52 ugers behandling eller på anden måde afbrudt.
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Oral kapsel
Oral kapsel placebo
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Durable Clinicohematologic Response (DCHR) Rate
Tidsramme: Up to approximately 52 weeks
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DCHR rate is the percentage of participants with DCHR, defined as a confirmed reduction of platelet count to ≤400 × 10^9/L, absence of white blood cell (WBC) count elevation to >10 × 10^9/L locally assessed to be due to ET, starting by Week 24 and maintained for at least 24 weeks, and the absence of any thrombotic or major hemorrhagic events or disease progression to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) by Week 52.
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Up to approximately 52 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Antal deltagere, der oplever en eller flere uønskede hændelser (AE'er)
Tidsramme: Op til cirka 52 uger
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En AE er enhver uønsket medicinsk hændelse hos en klinisk undersøgelsesdeltager, der er midlertidigt forbundet med brugen af undersøgelsesintervention, uanset om den anses for at være relateret til undersøgelsesinterventionen eller ej.
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Op til cirka 52 uger
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Antal deltagere, der stopper undersøgelsesintervention på grund af en AE
Tidsramme: Op til cirka 52 uger
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En AE er enhver uønsket medicinsk hændelse hos en klinisk undersøgelsesdeltager, der er midlertidigt forbundet med brugen af undersøgelsesintervention, uanset om den anses for at være relateret til undersøgelsesinterventionen eller ej.
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Op til cirka 52 uger
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Hematologic Response (HR) Rate
Tidsramme: Up to approximately 52 weeks
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HR rate is the percentage of participants with HR, HR is defined as the time from the first confirmed hematologic response to first documented evidence of confirmed platelet increase or confirmed WBC increase after latest confirmed hematologic response date.
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Up to approximately 52 weeks
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Clinicohematologic Response (CHR) Rate
Tidsramme: Up to approximately 52 weeks
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CHR rate is the percentage of participants with CHR, defined as a confirmed reduction of platelet count to ≤400 × 10^9/L, absence of white blood cell (WBC) count elevation to >10 × 10^9/L locally assessed to be due to ET, starting by Week 12 and maintained for at least 12 weeks, and the absence of any thrombotic or major hemorrhagic events or disease progression to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) by Week 52.
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Up to approximately 52 weeks
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Change From Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a Total Fatigue Score
Tidsramme: Baseline and pre-specified timepoints up to Week 52
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The PROMIS F SF-7a is a 7-item participant-reported assessment that measures both the experience of fatigue and the interference of fatigue on daily activities over the past week.
Response options are on a 5-point Likert scale, ranging from 1 = never to 5 = always.
The total score is used in the analysis and is obtained by summing keyed scores of all items.
Scores can range from 7 to 35, with higher scores indicating greater fatigue.
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Baseline and pre-specified timepoints up to Week 52
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Change From Baseline in MFSAF v4.0 Total Symptom Score
Tidsramme: Baseline and pre-specified timepoints up to Week 52
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The MFSAF v4.0 is a 7-item participant-reported myelofibrosis symptom assessment which asks respondents to report symptom severity at its worst for each of the 7 items on a 0 (Absent) to 10 (Worst Imaginable) numeric rating scale.
The change from baseline in MFSAF total score for all symptoms will be presented.
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Baseline and pre-specified timepoints up to Week 52
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Duration of Durable Clinicohematologic Response (DODCHR)
Tidsramme: Up to approximately 52 weeks
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For participants who demonstrate DCHR, DODCHR is defined as the time from the first documented evidence of confirmed reduction of platelet and WBC count until confirmed increase of platelet and WBC counts to above acceptable threshold, locally assessed to be due to ET after latest confirmed hematologic response date or thrombotic or major hemorrhagic events or disease progression to MF, MDS or AML.
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Up to approximately 52 weeks
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Duration of Clinicohematologic Response (DOCHR)
Tidsramme: Up to approximately 52 weeks
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For participants who demonstrate CHR, duration of clinicohematologic response is defined as the time from the first documented evidence of confirmed reduction of platelet and WBC count until confirmed increase of platelet and WBC counts to above acceptable threshold, locally assessed to be due to ET after latest confirmed hematologic response date or thrombotic or major hemorrhagic events or disease progression to MF, MDS or AML.
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Up to approximately 52 weeks
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Duration of Hematologic Response (DOHR)
Tidsramme: Up to approximately 52 weeks
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For participants who show confirmed hematologic response, DOHR is defined as the time from the first confirmed hematologic response to first documented evidence of confirmed platelet increase or confirmed WBC increase after latest confirmed hematologic response date.
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Up to approximately 52 weeks
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Percentage of Participants Who Experience Thrombotic Events
Tidsramme: Up to approximately 52 weeks
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Thrombotic events include but are not limited to new or recurrent acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep venous thrombosis, pulmonary embolism, thrombotic digital ischemia, or other thrombotic events.
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Up to approximately 52 weeks
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Percentage of Participants Who Experience Major Hemorrhagic Events
Tidsramme: Up to approximately 52 weeks
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Major hemorrhagic events include but are not limited to fatal bleeding, and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a decrease in hemoglobin level of 2 g/dL or more, or leading to transfusion of 2 or more units of whole blood or red cells.
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Up to approximately 52 weeks
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Percentage of Participants with Disease Progression to post-essential thrombocythemia myelofibrosis or myelodysplastic syndrome (MDS) /acute myeloid leukemia (AML)
Tidsramme: Up to approximately 52 weeks
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Disease progression rate is the percentage of participants with disease progression, defined as the transformation to post-essential thrombocythemia myelofibrosis, myelodysplastic syndrome, or AML as assessed by the adjudication committee.
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Up to approximately 52 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. juli 2024
Primær færdiggørelse (Anslået)
28. september 2027
Studieafslutning (Anslået)
24. marts 2028
Datoer for studieregistrering
Først indsendt
7. juni 2024
Først indsendt, der opfyldte QC-kriterier
7. juni 2024
Først opslået (Faktiske)
13. juni 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3543-007
- 2023 (U.S. NIH-bevilling/kontrakt: GRAMMY Museum Foundation)
- MK-3543-007 (Anden identifikator: MSD)
- jRCT2031240181 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
- U1111-1290-8287 (Registry Identifier: UTN)
- 2023-505232-36-00 (Registry Identifier: EU CT)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .