DOR/ISL hos HIV-1 antiretrovirala behandlingsnaiva deltagare (MK-8591A-053)
22 september 2026 uppdaterad av: Merck Sharp & Dohme LLC
En fas 3, randomiserad, aktivt kontrollerad, dubbelblind klinisk studie för att utvärdera den antiretrovirala aktiviteten, säkerheten och tolerabiliteten av Doravirin/Islatravir (DOR/ISL 100 mg/0,25 mg) en gång dagligen vid HIV-1-infekterad behandling-naiva Deltagare
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.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
537
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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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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, Dominikanska republiken, 10305
- Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250)
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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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Arizona
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Phoenix, Arizona, Förenta staterna, 85015
- Pueblo Family Physicians ( Site 5674)
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California
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Beverly Hills, California, Förenta staterna, 90211
- Pacific Oaks Medical Group ( Site 5681)
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Los Angeles, California, Förenta staterna, 90036
- Ruane Clinical Research Group, Inc ( Site 5658)
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Colorado
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Denver, Colorado, Förenta staterna, 80246
- Vivent Health ( Site 5694)
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20017
- Washington Health Institute ( Site 5689)
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Florida
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Ft. Pierce, Florida, Förenta staterna, 34982
- Midway Immunology and Research Center ( Site 5657)
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Miami, Florida, Förenta staterna, 33133
- AHF The Kinder Medical Group ( Site 5672)
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Miami Beach, Florida, Förenta staterna, 33140
- AHF South Beach ( Site 5663)
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Orlando, Florida, Förenta staterna, 32803
- Orlando Immunology Center ( Site 5654)
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Sarasota, Florida, Förenta staterna, 34237
- CAN Community Health - Sarasota ( Site 5668)
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West Palm Beach, Florida, Förenta staterna, 33407
- Triple O Research Institute, P.A ( Site 5666)
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Georgia
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Atlanta, Georgia, Förenta staterna, 30308
- Emory University and Grady Health System-Medicine ( Site 5690)
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Atlanta, Georgia, Förenta staterna, 30308
- Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673)
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Atlanta, Georgia, Förenta staterna, 30309
- Atlanta I.D. Group ( Site 5680)
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Decatur, Georgia, Förenta staterna, 30033
- Metro Infectious Diseases Consultants L.L.C. ( Site 5653)
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Macon, Georgia, Förenta staterna, 31201
- Mercer University, Department of Internal Medicine ( Site 5655)
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Rush University Medical Center-Infectious Disease ( Site 5671)
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Chicago, Illinois, Förenta staterna, 60612
- University of Illinois at Chicago-Project WISH ( Site 5685)
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Chicago, Illinois, Förenta staterna, 60613
- Howard Brown Health Center-Clinical Research ( Site 5665)
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Michigan
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Berkley, Michigan, Förenta staterna, 48072
- Be Well Medical Center ( Site 5650)
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Hospital ( Site 5667)
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Missouri
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Kansas City, Missouri, Förenta staterna, 64111
- KC CARE Health Center-Clinical Trials ( Site 5670)
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89106
- Jubilee Clinical Research ( Site 5679)
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Las Vegas, Nevada, Förenta staterna, 89106
- Las Vegas Research Center ( Site 5691)
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New Jersey
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Hillsborough, New Jersey, Förenta staterna, 08844
- ID Care ( Site 5676)
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Newark, New Jersey, Förenta staterna, 07102
- Saint Michael's Medical Center ( Site 5682)
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New York
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New York, New York, Förenta staterna, 10032
- Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688)
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The Bronx, New York, Förenta staterna, 10461
- Jacobi Medical Center ( Site 5683)
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28204
- Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675)
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Greensboro, North Carolina, Förenta staterna, 27401
- Regional Center for Infectious Diseases ( Site 5687)
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45267-0405
- University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662)
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Texas
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Austin, Texas, Förenta staterna, 78705
- Central Texas Clinical Research ( Site 5661)
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Bellaire, Texas, Förenta staterna, 77401
- St Hope Foundation ( Site 5659)
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Dallas, Texas, Förenta staterna, 75208
- Prism Health North Texas, Oak Cliff Health Center ( Site 5660)
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Dallas, Texas, Förenta staterna, 75246
- North Texas Infectious Diseases Consultants, P.A ( Site 5651)
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El Paso, Texas, Förenta staterna, 79902
- AXCES Research - Texas - El Paso ( Site 5692)
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Fort Worth, Texas, Förenta staterna, 76104
- Texas Centers for Infectious Disease Associates ( Site 5656)
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Longview, Texas, Förenta staterna, 75605
- DCOL Center for Clinical Research ( Site 5664)
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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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Ontario
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Hamilton, Ontario, Kanada, L8S 1A4
- Hamilton Health Sciences-Urgent Care Centre ( Site 5750)
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Toronto, Ontario, Kanada, M5G 2C4
- Toronto General Hospital ( Site 5753)
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Quebec
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Montreal, Quebec, Kanada, H2L 4P9
- Clinique Medicale lActuel ( Site 5752)
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Montreal, Quebec, Kanada, H4A 3J1
- McGill University Health Centre ( Site 5751)
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Saskatchewan
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Regina, Saskatchewan, Kanada, S4P 0W5
- Regina General Hospital ( Site 5754)
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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, Mexiko, 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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Canton of Basel-City
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Basel, Canton of Basel-City, Schweiz, 4031
- University Hospital Basel-Infectiology ( Site 8151)
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Canton of Geneva
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Geneva, Canton of Geneva, Schweiz, 1205
- Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150)
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Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352)
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Madrid, Spanien, 28015
- Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357)
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Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre ( Site 6355)
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Madrid, Spanien, 28046
- Hospital Universitario La Paz ( Site 6354)
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Málaga, Spanien, 29010
- Hospital Universitario Virgen de la Victoria ( Site 6359)
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Alicante
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Elche, Alicante, Spanien, 03202
- Hospital General Universitario de Elche-Infectius Disease ( Site 6358)
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Barcelona
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Badalona, Barcelona, Spanien, 08916
- Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351)
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Catalonia
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Barcelona, Catalonia, Spanien, 08036
- HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 6350)
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L'Hospitalet de Llobregat,Barcelona, Catalonia, Spanien, 08907
- Hospital Universitari de Bellvitge ( Site 6360)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spanien, 28007
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353)
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Madrid, Madrid, Comunidad de, Spanien, 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, Storbritannien, BS10 5NB
- Southmead Hospital ( Site 7952)
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England
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London, England, Storbritannien, E1 1BB
- Royal London Hospital ( Site 7951)
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Manchester, England, Storbritannien, M13 0FH
- The Hathersage Centre ( Site 7953)
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London, City of
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London, London, City of, Storbritannien, SE5 9RL
- King's College Hospital ( Site 7950)
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London, London, City of, Storbritannien, WC1E 6JB
- The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954)
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Free State
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Bloemfontein, Free State, Sydafrika, 9301
- Josha Research ( Site 6652)
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Gauteng
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Johannesburg, Gauteng, Sydafrika, 2013
- Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654)
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Johannesburg, Gauteng, Sydafrika, 2092
- Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661)
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Johannesburg, Gauteng, Sydafrika, 2193
- Ezintsha-Clinical Research Site ( Site 6656)
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KwaZulu-Natal
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Durban, KwaZulu-Natal, Sydafrika, 4052
- Wentworth Hospital ( Site 6653)
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Ladysmith, KwaZulu-Natal, Sydafrika, 3370
- Qhakaza Mbokodo Research Clinic ( Site 6659)
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Pietermaritzburg, KwaZulu-Natal, Sydafrika, 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, Sydafrika, 0250
- Madibeng Centre for Research ( Site 6660)
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Western Cape
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Cape Town, Western Cape, Sydafrika, 7500
- Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657)
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Cape Town, Western Cape, Sydafrika, 7925
- Desmond Tutu Health Foundation ( Site 6651)
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Paarl, Western Cape, Sydafrika, 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, Turkiet (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 7659)
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Ankara
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Altindağ, Ankara, Turkiet (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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Medical Director, Merck Sharp & Dohme LLC
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 mars 2023
Primärt slutförande (Faktisk)
13 oktober 2025
Avslutad studie (Beräknad)
5 augusti 2029
Studieregistreringsdatum
Först inskickad
20 januari 2023
Först inskickad som uppfyllde QC-kriterierna
20 januari 2023
Första postat (Faktisk)
30 januari 2023
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 oktober 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 8591A-053
- 2022-502099-22-00 (Registeridentifierare: EU CT)
- jRCT2031220720 (Registeridentifierare: jRCT)
- U1111-1283-2516 (Registeridentifierare: UTN)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .