HIV-1 항레트로바이러스 치료 경험이 없는 참가자의 DOR/ISL(MK-8591A-053)
2026년 9월 22일 업데이트: Merck Sharp & Dohme LLC
HIV-1 감염 치료 경험이 없는 환자에서 1일 1회 투여하는 도라비린/이슬라트라비르(DOR/ISL 100mg/0.25mg)의 항레트로바이러스 활성, 안전성 및 내약성을 평가하기 위한 3상, 무작위, 능동 제어, 이중 맹검 임상 연구 참가자들
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.
연구 개요
상태
상태
모집하지 않고 적극적으로
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (실제)
등록
537
단계
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Guatemala City, 과테말라, 01001
- CLINIPHARM ( Site 8352)
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Guatemala City, 과테말라, 01009
- Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 8350)
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Guatemala City, 과테말라, 01010
- CELAN,S.A ( Site 8351)
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Free State
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Bloemfontein, Free State, 남아프리카, 9301
- Josha Research ( Site 6652)
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Gauteng
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Johannesburg, Gauteng, 남아프리카, 2013
- Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654)
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Johannesburg, Gauteng, 남아프리카, 2092
- Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661)
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Johannesburg, Gauteng, 남아프리카, 2193
- Ezintsha-Clinical Research Site ( Site 6656)
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KwaZulu-Natal
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Durban, KwaZulu-Natal, 남아프리카, 4052
- Wentworth Hospital ( Site 6653)
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Ladysmith, KwaZulu-Natal, 남아프리카, 3370
- Qhakaza Mbokodo Research Clinic ( Site 6659)
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Pietermaritzburg, KwaZulu-Natal, 남아프리카, 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, 남아프리카, 0250
- Madibeng Centre for Research ( Site 6660)
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Western Cape
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Cape Town, Western Cape, 남아프리카, 7500
- Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657)
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Cape Town, Western Cape, 남아프리카, 7925
- Desmond Tutu Health Foundation ( Site 6651)
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Paarl, Western Cape, 남아프리카, 7626
- Be Part Yoluntu Centre ( Site 6650)
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Santo Domingo Province
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Santo Domingo de Guzman, Santo Domingo Province, 도미니카 공화국, 10305
- Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250)
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Hamburg, 독일, 20146
- ICH Study Center GmbH & Co. KG ( Site 6259)
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Hamburg, 독일, 20246
- Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 6260)
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Bavaria
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München, Bavaria, 독일, 80336
- Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio
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Brandenburg
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Freiburg, Brandenburg, 독일, 79106
- Universitaetsklinikum Freiburg ( Site 6256)
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, 독일, 53127
- Universitätsklinikum Bonn-Immunologie ( Site 6250)
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Kuala Lumpur, 말레이시아, 50586
- Hospital Kuala Lumpur ( Site 7773)
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Kedah
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Alor Star, Kedah, 말레이시아, 05460
- Hospital Sultanah Bahiyah ( Site 7776)
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Kuala Lumpur
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Lembah Pantai, Kuala Lumpur, 말레이시아, 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, 말레이시아, 10450
- Hospital Pulau Pinang ( Site 7779)
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Sarawak
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Kuching, Sarawak, 말레이시아, 93586
- Sarawak General Hospital ( Site 7772)
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Selangor
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Batu Caves, Selangor, 말레이시아, 68100
- Hospital Selayang ( Site 7770)
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Sungai Buloh, Selangor, 말레이시아, 47000
- Hospital Sungai Buloh ( Site 7778)
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Mexico City
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Mexico City, Mexico City, 멕시코, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 7251)
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Arizona
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Phoenix, Arizona, 미국, 85015
- Pueblo Family Physicians ( Site 5674)
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California
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Beverly Hills, California, 미국, 90211
- Pacific Oaks Medical Group ( Site 5681)
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Los Angeles, California, 미국, 90036
- Ruane Clinical Research Group, Inc ( Site 5658)
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Colorado
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Denver, Colorado, 미국, 80246
- Vivent Health ( Site 5694)
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20017
- Washington Health Institute ( Site 5689)
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Florida
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Ft. Pierce, Florida, 미국, 34982
- Midway Immunology and Research Center ( Site 5657)
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Miami, Florida, 미국, 33133
- AHF The Kinder Medical Group ( Site 5672)
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Miami Beach, Florida, 미국, 33140
- AHF South Beach ( Site 5663)
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Orlando, Florida, 미국, 32803
- Orlando Immunology Center ( Site 5654)
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Sarasota, Florida, 미국, 34237
- CAN Community Health - Sarasota ( Site 5668)
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West Palm Beach, Florida, 미국, 33407
- Triple O Research Institute, P.A ( Site 5666)
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Georgia
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Atlanta, Georgia, 미국, 30308
- Emory University and Grady Health System-Medicine ( Site 5690)
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Atlanta, Georgia, 미국, 30308
- Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673)
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Atlanta, Georgia, 미국, 30309
- Atlanta I.D. Group ( Site 5680)
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Decatur, Georgia, 미국, 30033
- Metro Infectious Diseases Consultants L.L.C. ( Site 5653)
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Macon, Georgia, 미국, 31201
- Mercer University, Department of Internal Medicine ( Site 5655)
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Illinois
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Chicago, Illinois, 미국, 60612
- Rush University Medical Center-Infectious Disease ( Site 5671)
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Chicago, Illinois, 미국, 60612
- University of Illinois at Chicago-Project WISH ( Site 5685)
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Chicago, Illinois, 미국, 60613
- Howard Brown Health Center-Clinical Research ( Site 5665)
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Michigan
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Berkley, Michigan, 미국, 48072
- Be Well Medical Center ( Site 5650)
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Detroit, Michigan, 미국, 48202
- Henry Ford Hospital ( Site 5667)
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Missouri
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Kansas City, Missouri, 미국, 64111
- KC CARE Health Center-Clinical Trials ( Site 5670)
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Nevada
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Las Vegas, Nevada, 미국, 89106
- Jubilee Clinical Research ( Site 5679)
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Las Vegas, Nevada, 미국, 89106
- Las Vegas Research Center ( Site 5691)
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New Jersey
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Hillsborough, New Jersey, 미국, 08844
- ID Care ( Site 5676)
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Newark, New Jersey, 미국, 07102
- Saint Michael's Medical Center ( Site 5682)
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New York
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New York, New York, 미국, 10032
- Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688)
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The Bronx, New York, 미국, 10461
- Jacobi Medical Center ( Site 5683)
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North Carolina
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Charlotte, North Carolina, 미국, 28204
- Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675)
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Greensboro, North Carolina, 미국, 27401
- Regional Center for Infectious Diseases ( Site 5687)
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Ohio
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Cincinnati, Ohio, 미국, 45267-0405
- University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662)
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Texas
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Austin, Texas, 미국, 78705
- Central Texas Clinical Research ( Site 5661)
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Bellaire, Texas, 미국, 77401
- St Hope Foundation ( Site 5659)
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Dallas, Texas, 미국, 75208
- Prism Health North Texas, Oak Cliff Health Center ( Site 5660)
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Dallas, Texas, 미국, 75246
- North Texas Infectious Diseases Consultants, P.A ( Site 5651)
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El Paso, Texas, 미국, 79902
- AXCES Research - Texas - El Paso ( Site 5692)
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Fort Worth, Texas, 미국, 76104
- Texas Centers for Infectious Disease Associates ( Site 5656)
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Longview, Texas, 미국, 75605
- DCOL Center for Clinical Research ( Site 5664)
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Canton of Basel-City
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Basel, Canton of Basel-City, 스위스, 4031
- University Hospital Basel-Infectiology ( Site 8151)
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Canton of Geneva
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Geneva, Canton of Geneva, 스위스, 1205
- Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150)
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Barcelona, 스페인, 08035
- Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352)
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Madrid, 스페인, 28015
- Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357)
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Madrid, 스페인, 28041
- Hospital Universitario 12 de Octubre ( Site 6355)
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Madrid, 스페인, 28046
- Hospital Universitario La Paz ( Site 6354)
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Málaga, 스페인, 29010
- Hospital Universitario Virgen de la Victoria ( Site 6359)
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Alicante
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Elche, Alicante, 스페인, 03202
- Hospital General Universitario de Elche-Infectius Disease ( Site 6358)
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Barcelona
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Badalona, Barcelona, 스페인, 08916
- Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351)
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Catalonia
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Barcelona, Catalonia, 스페인, 08036
- HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 6350)
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L'Hospitalet de Llobregat,Barcelona, Catalonia, 스페인, 08907
- Hospital Universitari de Bellvitge ( Site 6360)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, 스페인, 28007
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353)
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Madrid, Madrid, Comunidad de, 스페인, 28034
- Hospital Universitario Ramón y Cajal-ENFERMEDADES INFECCIOSAS ( Site 6361)
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Buenos Aires, 아르헨티나, C1405CKC
- Fundación IDEAA ( Site 5851)
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Córdoba, 아르헨티나, X5000JJS
- Instituto Oulton ( Site 5853)
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Buenos Aires
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CABA, Buenos Aires, 아르헨티나, C1427CEA
- Fundación Huésped ( Site 5850)
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Mar del Plata, Buenos Aires, 아르헨티나, 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, 아르헨티나, S2000PBJ
- Instituto CAICI SRL ( Site 5852)
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Bristol, City of
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Bristol, Bristol, City of, 영국, BS10 5NB
- Southmead Hospital ( Site 7952)
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England
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London, England, 영국, E1 1BB
- Royal London Hospital ( Site 7951)
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Manchester, England, 영국, M13 0FH
- The Hathersage Centre ( Site 7953)
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London, City of
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London, London, City of, 영국, SE5 9RL
- King's College Hospital ( Site 7950)
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London, London, City of, 영국, WC1E 6JB
- The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954)
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Haifa, 이스라엘, 3109601
- Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 6751)
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Jerusalem, 이스라엘, 9120
- Hadassah Medical Center-Infecious Disease ( Site 6752)
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Ramat Gan, 이스라엘, 5262100
- Sheba Medical Center-HIV unit ( Site 6753)
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Tel Aviv, 이스라엘, 6423906
- Sourasky Medical Center ( Site 6754)
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Osaka, 일본, 540-0006
- National Hospital Organization Osaka National Hospital ( Site 6952)
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Aichi-ken
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Nagoya, Aichi-ken, 일본, 460-0001
- National Hospital Organization Nagoya Medical Center ( Site 6953)
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Tokyo
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Shinjuku-ku, Tokyo, 일본, 160-0023
- Tokyo Medical University Hospital ( Site 6954)
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Shinjyuku-ku, Tokyo, 일본, 162-8655
- Center Hospital of the National Center for Global Health and Medicine ( Site 6951)
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Araucania
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Temuco, Araucania, 칠레, 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, 칠레, 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, 칠레, 7500710
- Biomedica Research Group-Infectology ( Site 5951)
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Santiago, Region M. de Santiago, 칠레, 7770086
- Espacio Eme ( Site 5952)
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Santiago, Region M. de Santiago, 칠레, 8330034
- Centro de Investigacion Clinicadela Universidad Catolica ( Site 5953)
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Santiago, Region M. de Santiago, 칠레, 8380420
- Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 5950)
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Ontario
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Hamilton, Ontario, 캐나다, L8S 1A4
- Hamilton Health Sciences-Urgent Care Centre ( Site 5750)
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Toronto, Ontario, 캐나다, M5G 2C4
- Toronto General Hospital ( Site 5753)
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Quebec
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Montreal, Quebec, 캐나다, H2L 4P9
- Clinique Medicale lActuel ( Site 5752)
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Montreal, Quebec, 캐나다, H4A 3J1
- McGill University Health Centre ( Site 5751)
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Saskatchewan
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Regina, Saskatchewan, 캐나다, S4P 0W5
- Regina General Hospital ( Site 5754)
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Kisumu, 케냐, 40100
- KEMRI-CMR-RCTP ( Site 8650)
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Nairobi City
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Nairobi, Nairobi City, 케냐, 00200
- CCR KEMRI (Center for Clinical Research) ( Site 8652)
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Nairobi, Nairobi City, 케냐, 00202
- PHRD KEMRI (Partners in Health Research & Development) ( Site 8651)
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Atlántico
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Barranquilla, Atlántico, 콜롬비아, 08001
- Ciensalud Ips S A S ( Site 6050)
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Barranquilla, Atlántico, 콜롬비아, 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., 콜롬비아, 110231
- Hospital Universitario San Ignacio-Infectious ( Site 6053)
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Bogotá, Bogota D.C., 콜롬비아, 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, 콜롬비아, 760032
- Fundación Valle del Lili ( Site 6052)
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Chiang Mai, 태국, 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, 태국, 10330
- HIV Netherlands Australia Thailand Research Collaboration ( Site 7851)
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Bangkok, Bangkok, 태국, 10700
- Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 7850)
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Ankara, 터키 (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 7659)
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Ankara
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Altindağ, Ankara, 터키 (Türkiye), 06230
- Hacettepe Universite Hastaneleri ( Site 7650)
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Ponce, 푸에르토 리코, 00716
- Ponce Medical School Foundation Inc. ( Site 7452)
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San Juan, 푸에르토 리코, 00909
- Clinical Research Puerto Rico ( Site 7450)
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San Juan, 푸에르토 리코, 00909
- HOPE Clinical Research ( Site 7451)
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Paris, 프랑스, 75018
- Hôpital Bichat - Claude-Bernard ( Site 6162)
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Paris, 프랑스, 75571
- Hôpital Saint Antoine ( Site 6158)
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Alpes-Maritimes
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Nice, Alpes-Maritimes, 프랑스, 06202
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153)
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Nord
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Tourcoing, Nord, 프랑스, 59200
- Tourcoing Hospital ( Site 6150)
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Île-de-France Region
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Bobigny, Île-de-France Region, 프랑스, 93000
- Hôpital Avicenne ( Site 6160)
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Paris, Île-de-France Region, 프랑스, 75010
- Hôpital Saint-Louis ( Site 6159)
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Paris, Île-de-France Region, 프랑스, 75013
- Pitie Salpetriere University Hospital ( Site 6156)
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth. |
|
활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2023년 3월 8일
기본 완료 (실제)
기본 완료
2025년 10월 13일
연구 완료 (추정된)
연구 완료
2029년 8월 5일
연구 등록 날짜
최초 제출
최초 제출
2023년 1월 20일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2023년 1월 20일
처음 게시됨 (실제)
처음 게시됨
2023년 1월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 10월 5일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 22일
마지막으로 확인됨
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 8591A-053
- 2022-502099-22-00 (레지스트리 식별자: EU CT)
- jRCT2031220720 (레지스트리 식별자: jRCT)
- U1111-1283-2516 (레지스트리 식별자: UTN)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .