DOR/ISL em participantes virgens de tratamento antirretroviral para HIV-1 (MK-8591A-053)
22 de setembro de 2026 atualizado por: Merck Sharp & Dohme LLC
Um estudo clínico duplo-cego, randomizado, controlado por ativo e fase 3 para avaliar a atividade antirretroviral, a segurança e a tolerabilidade de doravirina/islatravir (DOR/ISL 100 mg/0,25 mg) uma vez ao dia em pacientes infectados por HIV-1 virgens de tratamento participantes
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
537
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Hamburg, Alemanha, 20146
- ICH Study Center GmbH & Co. KG ( Site 6259)
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Hamburg, Alemanha, 20246
- Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 6260)
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Bavaria
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München, Bavaria, Alemanha, 80336
- Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio
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Brandenburg
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Freiburg, Brandenburg, Alemanha, 79106
- Universitaetsklinikum Freiburg ( Site 6256)
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Alemanha, 53127
- Universitätsklinikum Bonn-Immunologie ( Site 6250)
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Buenos Aires, Argentina, C1405CKC
- Fundación IDEAA ( Site 5851)
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Córdoba, Argentina, X5000JJS
- Instituto Oulton ( Site 5853)
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1427CEA
- Fundación Huésped ( Site 5850)
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Mar del Plata, Buenos Aires, Argentina, B7600FZO
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 5854)
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000PBJ
- Instituto CAICI SRL ( Site 5852)
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Ontario
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Hamilton, Ontario, Canadá, L8S 1A4
- Hamilton Health Sciences-Urgent Care Centre ( Site 5750)
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Toronto, Ontario, Canadá, M5G 2C4
- Toronto General Hospital ( Site 5753)
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Quebec
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Montreal, Quebec, Canadá, H2L 4P9
- Clinique Medicale lActuel ( Site 5752)
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Montreal, Quebec, Canadá, H4A 3J1
- McGill University Health Centre ( Site 5751)
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Saskatchewan
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Regina, Saskatchewan, Canadá, S4P 0W5
- Regina General Hospital ( Site 5754)
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Araucania
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Temuco, Araucania, Chile, 4781151
- Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 5955)
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Maule Region
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Talca, Maule Region, Chile, 3465584
- Clinica Universidad Catolica del Maule ( Site 5954)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7500710
- Biomedica Research Group-Infectology ( Site 5951)
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Santiago, Region M. de Santiago, Chile, 7770086
- Espacio Eme ( Site 5952)
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Santiago, Region M. de Santiago, Chile, 8330034
- Centro de Investigacion Clinicadela Universidad Catolica ( Site 5953)
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Santiago, Region M. de Santiago, Chile, 8380420
- Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 5950)
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Atlántico
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Barranquilla, Atlántico, Colômbia, 08001
- Ciensalud Ips S A S ( Site 6050)
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Barranquilla, Atlántico, Colômbia, 080020
- Clinica de la Costa S.A.S. ( Site 6055)
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Bogota D.C.
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Bogotá, Bogota D.C., Colômbia, 110231
- Hospital Universitario San Ignacio-Infectious ( Site 6053)
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Bogotá, Bogota D.C., Colômbia, 111321
- Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6051)
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colômbia, 760032
- Fundación Valle del Lili ( Site 6052)
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Barcelona, Espanha, 08035
- Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352)
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Madrid, Espanha, 28015
- Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357)
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Madrid, Espanha, 28041
- Hospital Universitario 12 de Octubre ( Site 6355)
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Madrid, Espanha, 28046
- Hospital Universitario La Paz ( Site 6354)
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Málaga, Espanha, 29010
- Hospital Universitario Virgen de la Victoria ( Site 6359)
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Alicante
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Elche, Alicante, Espanha, 03202
- Hospital General Universitario de Elche-Infectius Disease ( Site 6358)
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Barcelona
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Badalona, Barcelona, Espanha, 08916
- Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351)
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Catalonia
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Barcelona, Catalonia, Espanha, 08036
- HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 6350)
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L'Hospitalet de Llobregat,Barcelona, Catalonia, Espanha, 08907
- Hospital Universitari de Bellvitge ( Site 6360)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Espanha, 28007
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353)
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Madrid, Madrid, Comunidad de, Espanha, 28034
- Hospital Universitario Ramón y Cajal-ENFERMEDADES INFECCIOSAS ( Site 6361)
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Arizona
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Phoenix, Arizona, Estados Unidos, 85015
- Pueblo Family Physicians ( Site 5674)
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California
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Beverly Hills, California, Estados Unidos, 90211
- Pacific Oaks Medical Group ( Site 5681)
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Los Angeles, California, Estados Unidos, 90036
- Ruane Clinical Research Group, Inc ( Site 5658)
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Colorado
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Denver, Colorado, Estados Unidos, 80246
- Vivent Health ( Site 5694)
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20017
- Washington Health Institute ( Site 5689)
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Florida
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Ft. Pierce, Florida, Estados Unidos, 34982
- Midway Immunology and Research Center ( Site 5657)
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Miami, Florida, Estados Unidos, 33133
- AHF The Kinder Medical Group ( Site 5672)
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Miami Beach, Florida, Estados Unidos, 33140
- AHF South Beach ( Site 5663)
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Orlando, Florida, Estados Unidos, 32803
- Orlando Immunology Center ( Site 5654)
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Sarasota, Florida, Estados Unidos, 34237
- CAN Community Health - Sarasota ( Site 5668)
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West Palm Beach, Florida, Estados Unidos, 33407
- Triple O Research Institute, P.A ( Site 5666)
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- Emory University and Grady Health System-Medicine ( Site 5690)
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Atlanta, Georgia, Estados Unidos, 30308
- Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673)
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Atlanta, Georgia, Estados Unidos, 30309
- Atlanta I.D. Group ( Site 5680)
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Decatur, Georgia, Estados Unidos, 30033
- Metro Infectious Diseases Consultants L.L.C. ( Site 5653)
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Macon, Georgia, Estados Unidos, 31201
- Mercer University, Department of Internal Medicine ( Site 5655)
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center-Infectious Disease ( Site 5671)
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois at Chicago-Project WISH ( Site 5685)
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Chicago, Illinois, Estados Unidos, 60613
- Howard Brown Health Center-Clinical Research ( Site 5665)
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Michigan
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Berkley, Michigan, Estados Unidos, 48072
- Be Well Medical Center ( Site 5650)
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital ( Site 5667)
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Missouri
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Kansas City, Missouri, Estados Unidos, 64111
- KC CARE Health Center-Clinical Trials ( Site 5670)
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- Jubilee Clinical Research ( Site 5679)
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Las Vegas, Nevada, Estados Unidos, 89106
- Las Vegas Research Center ( Site 5691)
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New Jersey
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Hillsborough, New Jersey, Estados Unidos, 08844
- ID Care ( Site 5676)
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Newark, New Jersey, Estados Unidos, 07102
- Saint Michael's Medical Center ( Site 5682)
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688)
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The Bronx, New York, Estados Unidos, 10461
- Jacobi Medical Center ( Site 5683)
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675)
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Greensboro, North Carolina, Estados Unidos, 27401
- Regional Center for Infectious Diseases ( Site 5687)
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45267-0405
- University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662)
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Texas
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Austin, Texas, Estados Unidos, 78705
- Central Texas Clinical Research ( Site 5661)
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Bellaire, Texas, Estados Unidos, 77401
- St Hope Foundation ( Site 5659)
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Dallas, Texas, Estados Unidos, 75208
- Prism Health North Texas, Oak Cliff Health Center ( Site 5660)
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Dallas, Texas, Estados Unidos, 75246
- North Texas Infectious Diseases Consultants, P.A ( Site 5651)
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El Paso, Texas, Estados Unidos, 79902
- AXCES Research - Texas - El Paso ( Site 5692)
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Fort Worth, Texas, Estados Unidos, 76104
- Texas Centers for Infectious Disease Associates ( Site 5656)
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Longview, Texas, Estados Unidos, 75605
- DCOL Center for Clinical Research ( Site 5664)
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Paris, França, 75018
- Hôpital Bichat - Claude-Bernard ( Site 6162)
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Paris, França, 75571
- Hôpital Saint Antoine ( Site 6158)
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Alpes-Maritimes
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Nice, Alpes-Maritimes, França, 06202
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153)
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Nord
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Tourcoing, Nord, França, 59200
- Tourcoing Hospital ( Site 6150)
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Île-de-France Region
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Bobigny, Île-de-France Region, França, 93000
- Hôpital Avicenne ( Site 6160)
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Paris, Île-de-France Region, França, 75010
- Hôpital Saint-Louis ( Site 6159)
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Paris, Île-de-France Region, França, 75013
- Pitie Salpetriere University Hospital ( Site 6156)
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Guatemala City, Guatemala, 01001
- CLINIPHARM ( Site 8352)
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Guatemala City, Guatemala, 01009
- Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 8350)
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Guatemala City, Guatemala, 01010
- CELAN,S.A ( Site 8351)
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Haifa, Israel, 3109601
- Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 6751)
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Jerusalem, Israel, 9120
- Hadassah Medical Center-Infecious Disease ( Site 6752)
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Ramat Gan, Israel, 5262100
- Sheba Medical Center-HIV unit ( Site 6753)
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Tel Aviv, Israel, 6423906
- Sourasky Medical Center ( Site 6754)
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Osaka, Japão, 540-0006
- National Hospital Organization Osaka National Hospital ( Site 6952)
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Aichi-ken
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Nagoya, Aichi-ken, Japão, 460-0001
- National Hospital Organization Nagoya Medical Center ( Site 6953)
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Tokyo
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Shinjuku-ku, Tokyo, Japão, 160-0023
- Tokyo Medical University Hospital ( Site 6954)
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Shinjyuku-ku, Tokyo, Japão, 162-8655
- Center Hospital of the National Center for Global Health and Medicine ( Site 6951)
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Kuala Lumpur, Malásia, 50586
- Hospital Kuala Lumpur ( Site 7773)
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Kedah
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Alor Star, Kedah, Malásia, 05460
- Hospital Sultanah Bahiyah ( Site 7776)
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Kuala Lumpur
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Lembah Pantai, Kuala Lumpur, Malásia, 59100
- University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 7777)
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Pulau Pinang
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George Town, Pulau Pinang, Malásia, 10450
- Hospital Pulau Pinang ( Site 7779)
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Sarawak
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Kuching, Sarawak, Malásia, 93586
- Sarawak General Hospital ( Site 7772)
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Selangor
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Batu Caves, Selangor, Malásia, 68100
- Hospital Selayang ( Site 7770)
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Sungai Buloh, Selangor, Malásia, 47000
- Hospital Sungai Buloh ( Site 7778)
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Mexico City
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Mexico City, Mexico City, México, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 7251)
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Ponce, Porto Rico, 00716
- Ponce Medical School Foundation Inc. ( Site 7452)
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San Juan, Porto Rico, 00909
- Clinical Research Puerto Rico ( Site 7450)
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San Juan, Porto Rico, 00909
- HOPE Clinical Research ( Site 7451)
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Kisumu, Quênia, 40100
- KEMRI-CMR-RCTP ( Site 8650)
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Nairobi City
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Nairobi, Nairobi City, Quênia, 00200
- CCR KEMRI (Center for Clinical Research) ( Site 8652)
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Nairobi, Nairobi City, Quênia, 00202
- PHRD KEMRI (Partners in Health Research & Development) ( Site 8651)
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Bristol, City of
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Bristol, Bristol, City of, Reino Unido, BS10 5NB
- Southmead Hospital ( Site 7952)
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England
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London, England, Reino Unido, E1 1BB
- Royal London Hospital ( Site 7951)
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Manchester, England, Reino Unido, M13 0FH
- The Hathersage Centre ( Site 7953)
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London, City of
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London, London, City of, Reino Unido, SE5 9RL
- King's College Hospital ( Site 7950)
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London, London, City of, Reino Unido, WC1E 6JB
- The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954)
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Santo Domingo Province
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Santo Domingo de Guzman, Santo Domingo Province, República Dominicana, 10305
- Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250)
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Canton of Basel-City
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Basel, Canton of Basel-City, Suíça, 4031
- University Hospital Basel-Infectiology ( Site 8151)
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Canton of Geneva
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Geneva, Canton of Geneva, Suíça, 1205
- Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150)
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Chiang Mai, Tailândia, 50200
- Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 7852
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Bangkok
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Bangkok, Bangkok, Tailândia, 10330
- HIV Netherlands Australia Thailand Research Collaboration ( Site 7851)
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Bangkok, Bangkok, Tailândia, 10700
- Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 7850)
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Ankara, Turquia (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 7659)
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Ankara
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Altindağ, Ankara, Turquia (Türkiye), 06230
- Hacettepe Universite Hastaneleri ( Site 7650)
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Free State
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Bloemfontein, Free State, África do Sul, 9301
- Josha Research ( Site 6652)
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Gauteng
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Johannesburg, Gauteng, África do Sul, 2013
- Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654)
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Johannesburg, Gauteng, África do Sul, 2092
- Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661)
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Johannesburg, Gauteng, África do Sul, 2193
- Ezintsha-Clinical Research Site ( Site 6656)
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KwaZulu-Natal
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Durban, KwaZulu-Natal, África do Sul, 4052
- Wentworth Hospital ( Site 6653)
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Ladysmith, KwaZulu-Natal, África do Sul, 3370
- Qhakaza Mbokodo Research Clinic ( Site 6659)
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Pietermaritzburg, KwaZulu-Natal, África do Sul, 3201
- Human Sciences Research Council-Centre for Community Based Research ( Site 6664)
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North West
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Brits, North West, África do Sul, 0250
- Madibeng Centre for Research ( Site 6660)
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Western Cape
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Cape Town, Western Cape, África do Sul, 7500
- Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657)
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Cape Town, Western Cape, África do Sul, 7925
- Desmond Tutu Health Foundation ( Site 6651)
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Paarl, Western Cape, África do Sul, 7626
- Be Part Yoluntu Centre ( Site 6650)
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening
- Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
- If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration
Exclusion Criteria:
- Has HIV-2 infection
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening
- Has active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive).
- Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]) and lab values are consistent with cirrhosis
- Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
- Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: DOR/ISL
Participants take DOR/ISL and placebo to BIC/FTC/TAF once daily (qd) for 144 weeks. |
Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.
Outros nomes:
Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth. |
|
Comparador Ativo: BIC/FTC/TAF
Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 144 weeks. |
Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth. Placebo tablet matched to DOR/ISL tablet taken by mouth. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
Prazo: Week 48
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay with a lower limit of detection of <50 copies/mL. |
Week 48
|
|
Percentage of participants experiencing ≥1 adverse event (AE) through Week 48
Prazo: Up to 48 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 48 weeks
|
|
Percentage of participants discontinuing from study treatment due to an AE through Week 48
Prazo: Up to 48 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 48 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96
Prazo: Week 96
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL. |
Week 96
|
|
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 144
Prazo: Week 144
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL. |
Week 144
|
|
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48
Prazo: Week 48
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL. |
Week 48
|
|
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96
Prazo: Week 96
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL. |
Week 96
|
|
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 144
Prazo: Week 144
|
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL. |
Week 144
|
|
Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48
Prazo: Baseline (Day 1) and Week 48
|
CD4+ T-cells are quantified with a T and B lymphocyte and natural killer cell (TBNK) panel. |
Baseline (Day 1) and Week 48
|
|
Change from baseline in CD4+ T-cells at Week 96
Prazo: Baseline (Day 1) and Week 96
|
CD4+ T-cells are quantified with a TBNK panel. |
Baseline (Day 1) and Week 96
|
|
Change from baseline in CD4+ T-cells at Week 144
Prazo: Baseline (Day 1) and Week 144
|
CD4+ T-cells are quantified with a TBNK panel. |
Baseline (Day 1) and Week 144
|
|
Incidence of viral drug resistance
Prazo: Up to 96 weeks
|
Plasma samples will be collected for genotypic and phenotypic HIV-1 viral drug resistance testing and used to assess resistance-associated substitutions and viral susceptibility as applicable during the study. |
Up to 96 weeks
|
|
Change from baseline in body weight at Week 48
Prazo: Baseline (Day 1) and Week 48
|
Body weight will be collected throughout the study. |
Baseline (Day 1) and Week 48
|
|
Change from baseline in body weight at Week 96
Prazo: Baseline (Day 1) and Week 96
|
Body weight will be collected throughout the study. |
Baseline (Day 1) and Week 96
|
|
Change from baseline in body weight at Week 144
Prazo: Baseline (Day 1) and Week 144
|
Body weight will be collected throughout the study. |
Baseline (Day 1) and Week 144
|
|
Percentage of participants experiencing ≥1 AE through Week 144
Prazo: Up to 144 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 144 weeks
|
|
Percentage of participants discontinuing from study treatment due to an AE through Week 144
Prazo: Up to 144 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 144 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de março de 2023
Conclusão Primária (Real)
13 de outubro de 2025
Conclusão do estudo (Estimado)
5 de agosto de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
20 de janeiro de 2023
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de janeiro de 2023
Primeira postagem (Real)
30 de janeiro de 2023
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de outubro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 8591A-053
- 2022-502099-22-00 (Identificador de registro: EU CT)
- jRCT2031220720 (Identificador de registro: jRCT)
- U1111-1283-2516 (Identificador de registro: UTN)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .