DOR/ISL hos HIV-1 antiretroviral behandling-naive deltakere (MK-8591A-053)
22. september 2026 oppdatert av: Merck Sharp & Dohme LLC
En fase 3, randomisert, aktivt kontrollert, dobbeltblind klinisk studie for å evaluere antiretroviral aktivitet, sikkerhet og tolerabilitet av Doravirine/Islatravir (DOR/ISL 100 mg/0,25 mg) én gang daglig i HIV-1-infisert behandling-naive Deltakere
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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
537
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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, Canada, L8S 1A4
- Hamilton Health Sciences-Urgent Care Centre ( Site 5750)
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital ( Site 5753)
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Quebec
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Montreal, Quebec, Canada, H2L 4P9
- Clinique Medicale lActuel ( Site 5752)
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Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Centre ( Site 5751)
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Saskatchewan
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Regina, Saskatchewan, Canada, 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, Colombia, 08001
- Ciensalud Ips S A S ( Site 6050)
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Barranquilla, Atlántico, Colombia, 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., Colombia, 110231
- Hospital Universitario San Ignacio-Infectious ( Site 6053)
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Bogotá, Bogota D.C., Colombia, 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, Colombia, 760032
- Fundación Valle del Lili ( Site 6052)
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Santo Domingo Province
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Santo Domingo de Guzman, Santo Domingo Province, Den dominikanske republikk, 10305
- Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250)
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Arizona
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Phoenix, Arizona, Forente stater, 85015
- Pueblo Family Physicians ( Site 5674)
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California
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Beverly Hills, California, Forente stater, 90211
- Pacific Oaks Medical Group ( Site 5681)
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Los Angeles, California, Forente stater, 90036
- Ruane Clinical Research Group, Inc ( Site 5658)
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Colorado
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Denver, Colorado, Forente stater, 80246
- Vivent Health ( Site 5694)
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20017
- Washington Health Institute ( Site 5689)
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Florida
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Ft. Pierce, Florida, Forente stater, 34982
- Midway Immunology and Research Center ( Site 5657)
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Miami, Florida, Forente stater, 33133
- AHF The Kinder Medical Group ( Site 5672)
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Miami Beach, Florida, Forente stater, 33140
- AHF South Beach ( Site 5663)
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Orlando, Florida, Forente stater, 32803
- Orlando Immunology Center ( Site 5654)
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Sarasota, Florida, Forente stater, 34237
- CAN Community Health - Sarasota ( Site 5668)
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West Palm Beach, Florida, Forente stater, 33407
- Triple O Research Institute, P.A ( Site 5666)
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Georgia
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Atlanta, Georgia, Forente stater, 30308
- Emory University and Grady Health System-Medicine ( Site 5690)
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Atlanta, Georgia, Forente stater, 30308
- Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673)
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Atlanta, Georgia, Forente stater, 30309
- Atlanta I.D. Group ( Site 5680)
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Decatur, Georgia, Forente stater, 30033
- Metro Infectious Diseases Consultants L.L.C. ( Site 5653)
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Macon, Georgia, Forente stater, 31201
- Mercer University, Department of Internal Medicine ( Site 5655)
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Rush University Medical Center-Infectious Disease ( Site 5671)
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Chicago, Illinois, Forente stater, 60612
- University of Illinois at Chicago-Project WISH ( Site 5685)
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Chicago, Illinois, Forente stater, 60613
- Howard Brown Health Center-Clinical Research ( Site 5665)
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Michigan
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Berkley, Michigan, Forente stater, 48072
- Be Well Medical Center ( Site 5650)
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital ( Site 5667)
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Missouri
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Kansas City, Missouri, Forente stater, 64111
- KC CARE Health Center-Clinical Trials ( Site 5670)
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Nevada
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Las Vegas, Nevada, Forente stater, 89106
- Jubilee Clinical Research ( Site 5679)
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Las Vegas, Nevada, Forente stater, 89106
- Las Vegas Research Center ( Site 5691)
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New Jersey
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Hillsborough, New Jersey, Forente stater, 08844
- ID Care ( Site 5676)
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Newark, New Jersey, Forente stater, 07102
- Saint Michael's Medical Center ( Site 5682)
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New York
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New York, New York, Forente stater, 10032
- Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688)
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The Bronx, New York, Forente stater, 10461
- Jacobi Medical Center ( Site 5683)
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North Carolina
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Charlotte, North Carolina, Forente stater, 28204
- Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675)
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Greensboro, North Carolina, Forente stater, 27401
- Regional Center for Infectious Diseases ( Site 5687)
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Ohio
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Cincinnati, Ohio, Forente stater, 45267-0405
- University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662)
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Texas
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Austin, Texas, Forente stater, 78705
- Central Texas Clinical Research ( Site 5661)
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Bellaire, Texas, Forente stater, 77401
- St Hope Foundation ( Site 5659)
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Dallas, Texas, Forente stater, 75208
- Prism Health North Texas, Oak Cliff Health Center ( Site 5660)
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Dallas, Texas, Forente stater, 75246
- North Texas Infectious Diseases Consultants, P.A ( Site 5651)
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El Paso, Texas, Forente stater, 79902
- AXCES Research - Texas - El Paso ( Site 5692)
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Fort Worth, Texas, Forente stater, 76104
- Texas Centers for Infectious Disease Associates ( Site 5656)
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Longview, Texas, Forente stater, 75605
- DCOL Center for Clinical Research ( Site 5664)
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Paris, Frankrike, 75018
- Hôpital Bichat - Claude-Bernard ( Site 6162)
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Paris, Frankrike, 75571
- Hôpital Saint Antoine ( Site 6158)
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Frankrike, 06202
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153)
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Nord
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Tourcoing, Nord, Frankrike, 59200
- Tourcoing Hospital ( Site 6150)
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Île-de-France Region
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Bobigny, Île-de-France Region, Frankrike, 93000
- Hôpital Avicenne ( Site 6160)
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Paris, Île-de-France Region, Frankrike, 75010
- Hôpital Saint-Louis ( Site 6159)
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Paris, Île-de-France Region, Frankrike, 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, Japan, 540-0006
- National Hospital Organization Osaka National Hospital ( Site 6952)
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 460-0001
- National Hospital Organization Nagoya Medical Center ( Site 6953)
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Tokyo
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Shinjuku-ku, Tokyo, Japan, 160-0023
- Tokyo Medical University Hospital ( Site 6954)
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Shinjyuku-ku, Tokyo, Japan, 162-8655
- Center Hospital of the National Center for Global Health and Medicine ( Site 6951)
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Kisumu, Kenya, 40100
- KEMRI-CMR-RCTP ( Site 8650)
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Nairobi City
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Nairobi, Nairobi City, Kenya, 00200
- CCR KEMRI (Center for Clinical Research) ( Site 8652)
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Nairobi, Nairobi City, Kenya, 00202
- PHRD KEMRI (Partners in Health Research & Development) ( Site 8651)
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Kuala Lumpur, Malaysia, 50586
- Hospital Kuala Lumpur ( Site 7773)
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Kedah
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Alor Star, Kedah, Malaysia, 05460
- Hospital Sultanah Bahiyah ( Site 7776)
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Kuala Lumpur
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Lembah Pantai, Kuala Lumpur, Malaysia, 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, Malaysia, 10450
- Hospital Pulau Pinang ( Site 7779)
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Sarawak
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Kuching, Sarawak, Malaysia, 93586
- Sarawak General Hospital ( Site 7772)
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Selangor
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Batu Caves, Selangor, Malaysia, 68100
- Hospital Selayang ( Site 7770)
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Sungai Buloh, Selangor, Malaysia, 47000
- Hospital Sungai Buloh ( Site 7778)
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Mexico City
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Mexico City, Mexico City, Mexico, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 7251)
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Ponce, Puerto Rico, 00716
- Ponce Medical School Foundation Inc. ( Site 7452)
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San Juan, Puerto Rico, 00909
- Clinical Research Puerto Rico ( Site 7450)
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San Juan, Puerto Rico, 00909
- HOPE Clinical Research ( Site 7451)
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Barcelona, Spania, 08035
- Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352)
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Madrid, Spania, 28015
- Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357)
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Madrid, Spania, 28041
- Hospital Universitario 12 de Octubre ( Site 6355)
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Madrid, Spania, 28046
- Hospital Universitario La Paz ( Site 6354)
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Málaga, Spania, 29010
- Hospital Universitario Virgen de la Victoria ( Site 6359)
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Alicante
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Elche, Alicante, Spania, 03202
- Hospital General Universitario de Elche-Infectius Disease ( Site 6358)
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Barcelona
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Badalona, Barcelona, Spania, 08916
- Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351)
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Catalonia
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Barcelona, Catalonia, Spania, 08036
- HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 6350)
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L'Hospitalet de Llobregat,Barcelona, Catalonia, Spania, 08907
- Hospital Universitari de Bellvitge ( Site 6360)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spania, 28007
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353)
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Madrid, Madrid, Comunidad de, Spania, 28034
- Hospital Universitario Ramón y Cajal-ENFERMEDADES INFECCIOSAS ( Site 6361)
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Bristol, City of
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Bristol, Bristol, City of, Storbritannia, BS10 5NB
- Southmead Hospital ( Site 7952)
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England
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London, England, Storbritannia, E1 1BB
- Royal London Hospital ( Site 7951)
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Manchester, England, Storbritannia, M13 0FH
- The Hathersage Centre ( Site 7953)
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London, City of
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London, London, City of, Storbritannia, SE5 9RL
- King's College Hospital ( Site 7950)
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London, London, City of, Storbritannia, WC1E 6JB
- The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954)
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Canton of Basel-City
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Basel, Canton of Basel-City, Sveits, 4031
- University Hospital Basel-Infectiology ( Site 8151)
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Canton of Geneva
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Geneva, Canton of Geneva, Sveits, 1205
- Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150)
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Free State
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Bloemfontein, Free State, Sør-Afrika, 9301
- Josha Research ( Site 6652)
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Gauteng
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Johannesburg, Gauteng, Sør-Afrika, 2013
- Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654)
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Johannesburg, Gauteng, Sør-Afrika, 2092
- Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661)
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Johannesburg, Gauteng, Sør-Afrika, 2193
- Ezintsha-Clinical Research Site ( Site 6656)
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KwaZulu-Natal
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Durban, KwaZulu-Natal, Sør-Afrika, 4052
- Wentworth Hospital ( Site 6653)
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Ladysmith, KwaZulu-Natal, Sør-Afrika, 3370
- Qhakaza Mbokodo Research Clinic ( Site 6659)
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Pietermaritzburg, KwaZulu-Natal, Sør-Afrika, 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, Sør-Afrika, 0250
- Madibeng Centre for Research ( Site 6660)
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Western Cape
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Cape Town, Western Cape, Sør-Afrika, 7500
- Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657)
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Cape Town, Western Cape, Sør-Afrika, 7925
- Desmond Tutu Health Foundation ( Site 6651)
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Paarl, Western Cape, Sør-Afrika, 7626
- Be Part Yoluntu Centre ( Site 6650)
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Chiang Mai, Thailand, 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, Thailand, 10330
- HIV Netherlands Australia Thailand Research Collaboration ( Site 7851)
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Bangkok, Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 7850)
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Ankara, Tyrkia (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 7659)
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Ankara
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Altindağ, Ankara, Tyrkia (Türkiye), 06230
- Hacettepe Universite Hastaneleri ( Site 7650)
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Hamburg, Tyskland, 20146
- ICH Study Center GmbH & Co. KG ( Site 6259)
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Hamburg, Tyskland, 20246
- Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 6260)
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Bavaria
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München, Bavaria, Tyskland, 80336
- Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio
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Brandenburg
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Freiburg, Brandenburg, Tyskland, 79106
- Universitaetsklinikum Freiburg ( Site 6256)
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Tyskland, 53127
- Universitätsklinikum Bonn-Immunologie ( Site 6250)
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth. |
|
Aktiv komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. mars 2023
Primær fullføring (Faktiske)
13. oktober 2025
Studiet fullført (Antatt)
5. august 2029
Datoer for studieregistrering
Først innsendt
20. januar 2023
Først innsendt som oppfylte QC-kriteriene
20. januar 2023
Først lagt ut (Faktiske)
30. januar 2023
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 8591A-053
- 2022-502099-22-00 (Registeridentifikator: EU CT)
- jRCT2031220720 (Registeridentifikator: jRCT)
- U1111-1283-2516 (Registeridentifikator: UTN)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .