- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05595642
En undersøgelse til evaluering af Astegolimab hos deltagere med kronisk obstruktiv lungesygdom (ARNASA)
19. maj 2026 opdateret af: Hoffmann-La Roche
En fase III, randomiseret, dobbeltblind, placebokontrolleret, multicenterundersøgelse til evaluering af effektiviteten og sikkerheden af Astegolimab hos patienter med kronisk obstruktiv lungesygdom
Denne undersøgelse vil evaluere effektiviteten og sikkerheden af astegolimab sammenlignet med placebo hos deltagere med kronisk obstruktiv lungesygdom (KOL), som er tidligere eller nuværende rygere og har en historie med hyppige eksacerbationer.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1290
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina, C1122AAK
- Fundacion Faicep
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Buenos Aires, Argentina, 12345
- Consultorios Medicos Organizacion de Buen Ayre SRL
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Buenos Aires, Argentina, C1025
- Nexo Salud Investigacion Clinica - Riobamba 429
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Buenos Aires, Argentina, C1027AAP
- CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC
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Buenos Aires, Argentina, C1425
- Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias
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Buenos Aires, Argentina, C1430
- AES - AS - Glenny Corp. S.A. Buenos Aires
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Concepción del Uruguay, Argentina, 3260
- Centro de Medicina Respiratoria
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Córdoba, Argentina, X5000BSQ
- Sanatorio de la Cañada
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La Plata, Argentina, 1900
- Framingham Centro Medico
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La Plata, Argentina, 1904
- Centro Medico Capital
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La Plata, Argentina, B1900BNN
- Centro Platense en Investigaciones Respiratorias
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Mendoza, Argentina, M5500AYB
- Centro Medico Dharma
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Paraná, Argentina, 3100
- Centro Privado de Medicina Respiratoria
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Ranelagh, Berazategui, Argentina, 1886
- Sala de primeros auxilios Alberto Mignaburu
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Rosario, Argentina, S2000DEJ
- Instituto Medico de la Fundacion Estudios Clinicos
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Rosario, Argentina, S2013JKR
- Servicio de Investigacion de Patologias Alergicas-Instituto ABC
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Rosario, Argentina, S2013KZD
- Sanatorio Parque de Rosario
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San Miguel de Tucumán, Argentina, 4000
- Centro Modelo de Cardiologia
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San Nicolás de los Arroyos, Argentina, B2900
- Centro Medico San Nicolas Grupo Orono
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San Salvador, Argentina, E3218CHH
- CEPROSS- Centro Profesional San Salvador
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Santa Fe, Argentina, S3000ASF
- Instituto Del Buen Aire
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Santa Fe, Argentina, S3000
- Centro de Diagnostico Y Rehabilitacion
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South Australia
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Midland, South Australia, Australien, 6056
- Institute for Respiratory Health - Midland
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Bruges, Belgien, 8000
- AZ Sint-Jan Brugge-Oostende
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Brussels, Belgien, 1200
- Cliniques Universitaires Saint-Luc
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Brussels, Belgien, 1090
- Universitair Ziekenhuis Brussel
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Liège, Belgien, 4000
- CHU de Liège
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Rio de Janeiro, Brasilien, 20241-180
- IBPCLIN Instituto Brasil de Pesquisa Clinica
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São Paulo, Brasilien, 05403-000
- Instituto do Coracao - HCFMUSP
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Federal District
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Brasília, Federal District, Brasilien, 70200-730
- L2IP ?Instituto de Pesquisas Clínicas Ltda.
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 30150-221
- Santa Casa de Misericordia de Belo Horizonte - PPDS
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90610-000
- Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
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Porto Alegre, Rio Grande do Sul, Brasilien, 90480-000
- LMK Servicos Medicos SS
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São Paulo
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Santo André, São Paulo, Brasilien, 09060-650
- Faculdade de Medicina do ABC - FMABC
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São Bernardo do Campo, São Paulo, Brasilien, 09715-090
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
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Blagoevgrad, Bulgarien, 2700
- Multiprofile Hospital for Active Treatment Puls AD PPDS
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Dimitrovgrad, Bulgarien, 6400
- Multiprofile Hospital For Active Treatment Sveta Ekaterina - Dimitrovgrad EOOD
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Gabrovo, Bulgarien, 5300
- Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC
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Montana, Bulgarien, 3400
- Medical Center Hera EOOD
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Plovdiv, Bulgarien, 4003
- Multiprofile Hospital for Active Treatment Plovdiv
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Razgrad, Bulgarien, 7200
- Multiprofile Hospital for Active Treatment Sv. Ivan Rilski- Razgrad AD
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Shumen, Bulgarien, 9700
- Multiprofile Hospital for Active Treatment Shumen
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Silistra, Bulgarien, 7500
- Multiprofile Hospital for Active Treatment - Silistra AD
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Smolyan, Bulgarien, 4700
- Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD
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Sofia, Bulgarien, 1431
- Diagnostic-Consultative Center Aleksandrovska EOOD
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Sofia, Bulgarien, 1680
- Diagnostic- Consultative Center Convex EOOD
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Sofia, Bulgarien, 1233
- Fifth Multiprofile Hospital for Active Treatment - Sofia EAD
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Sofia, Bulgarien, 1784
- AES DRS Medical Center Synexus Sofia EOOD
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Varna, Bulgarien, 9020
- Diagnostic Consultative Centre Mladost?M OOD
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Veliko Tarnovo, Bulgarien, 5000
- Medical Center Tara OOD
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Québec, Canada, G1V 4G5
- Centre Hospitalier de l'Université Laval
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Alberta
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Edmonton, Alberta, Canada, T5J 3S9
- Edmonton Respiratory Consultants
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Sherwood Park, Alberta, Canada, T8H 0N2
- Synergy Respiratory & Cardiac Care - Synergy Wellness Centre Location
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
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Ontario
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Ajax, Ontario, Canada, L1S 2J5
- Dynamic Drug Advancement Ltd.
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Toronto, Ontario, Canada, M5T 3A9
- Inspiration Research
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Windsor, Ontario, Canada, N8X 1T3
- Dr. Syed Anees Medicine Profession Corporation
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Windsor, Ontario, Canada, N8X 5A6
- Dr Anil Dhar Professional Medicine Corporation
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Quebec
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Montreal, Quebec, Canada, H1Y 3H5
- Recherche GCP Research
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Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
- Clinique de pneumologie et du sommeil de Lanaudière
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Pavie Gallegos, Chile, 2340000
- Centro Respiratorio Integral LTDA. (CENRESIN)
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Vitacura, Chile, 7630000
- Fundacion Medica San Cristobal
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Viña del Mar, Chile, 2520598
- Oncocentro APYS
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Næstved, Danmark, 4700
- Naestved Sygehus
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Roskilde, Danmark, 4000
- Sjaellands Universitetshospital, Roskilde
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Bellshill, Det Forenede Kongerige, ML4 3NJ
- AES - DRS - Synexus Scotland Clinical Research Centre
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Birmingham, Det Forenede Kongerige, B15 2SQ
- AES - DRS - Synexus Midlands Clinical Research Centre
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Cardiff, Det Forenede Kongerige, CF15 9SS
- AES - DRS - Synexus Wales Clinical Research Centre
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Chesterfield, Det Forenede Kongerige, S40 4AA
- Royal Primary Care - Ashgate Manor
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Chorley, Det Forenede Kongerige, PR7 7NA
- AES - DRS - NW Consortium Lancashire
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Edinburgh, Det Forenede Kongerige, EH16 4SA
- Royal Infirmary of Edinburgh
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Hexham, Det Forenede Kongerige, NE46 1QJ
- AES - DRS - Synexus Hexham Clinical Research Centre
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Lancaster, Det Forenede Kongerige, LA1 4RP
- Royal Lancaster Infirmary
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Leeds, Det Forenede Kongerige, LS9 7TF
- St James University Hospital
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Liverpool, Det Forenede Kongerige, L32 2AN
- AES - DRS - NW Consortium Merseyside
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London, Det Forenede Kongerige, SE1 7EH
- St Thomas' Hospital
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London, Det Forenede Kongerige, N12 8BU
- Velocity Clinical Research North London - Percy Road - PPDS
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Yorkshire
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Cottingham, Yorkshire, Det Forenede Kongerige, HU16 5JQ
- Castle Hill Hospital
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Caloocan, Filippinerne, 1442
- Manila Central University-Filemon D Tanchoco Medical Foundation
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Dasmariñas, Filippinerne, 4114
- CARE CT Group Inc.
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Iloilo City, Filippinerne, 5000
- West Visayas State University Medical Center
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Iloilo City, Filippinerne, 5000
- Healthlink Medicalsurgicaldental Clinic and Diagnostic Center
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Lipa City, Filippinerne, 4217
- Mary Mediatrix Medical Center
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Quezon City, Filippinerne, 1109
- Quirino Memorial Medical Center
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Quezon City, Filippinerne, 1100
- Philippine Heart Center
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama at Birmingham
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Dothan, Alabama, Forenede Stater, 36305
- SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
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Arizona
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Glendale, Arizona, Forenede Stater, 85306-4669
- Pulmonary Associates PA
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Tucson, Arizona, Forenede Stater, 85741-3118
- AES - DRS - Synexus Clinical Research US, Inc. - Tucson
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California
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Bakersfield, California, Forenede Stater, 93301
- Kern Research
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Walnut Creek, California, Forenede Stater, 94598
- Allergy & Asthma Medical Group of the Bay Area
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Florida
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Greenacres City, Florida, Forenede Stater, 33467-2979
- Finlay Medical Research Corporation
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Miami, Florida, Forenede Stater, 33014
- San Marcus Research Clinic Inc.
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Miami, Florida, Forenede Stater, 33173
- Research Institute of South Florida Inc
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Miami, Florida, Forenede Stater, 33144-2155
- Oceane7 Medical & Research Center, Inc.
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Miami, Florida, Forenede Stater, 33155-3265
- Avantis Clinical Research, LLC
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Miami, Florida, Forenede Stater, 33175-3434
- Diverse Clinical Research, LLC
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Orlando, Florida, Forenede Stater, 32803
- Central Florida Pulmonary Group, PA
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The Villages, Florida, Forenede Stater, 32162-7116
- AES - DRS - Synexus Clinical Research US, Inc. - The Villages
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Georgia
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Atlanta, Georgia, Forenede Stater, 30328
- AES - DRS - Synexus Clinical Research US, Inc. - Atlanta
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Columbus, Georgia, Forenede Stater, 31904-2954
- Allergy Center at Brookstone Research - Centricity Research - HyperCore - PPD
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Stonecrest, Georgia, Forenede Stater, 30038-2649
- Pivotal Research Solutions
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Indiana
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Hammond, Indiana, Forenede Stater, 46324-2213
- ASHA Clinical Research - ClinEdge - PPDS
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40504
- The Research Group of Lexington, LLC
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70115
- Best Clinical Trials
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Maine
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Bangor, Maine, Forenede Stater, 04401-5691
- Paul A. Shapero, MD, PA
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Michigan
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Farmington Hills, Michigan, Forenede Stater, 48336-2817
- Pulmonary Research Institute of Southeast Michigan
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Flint, Michigan, Forenede Stater, 48504-4730
- Flushing Road Internal Medicine and Pediatrics - F
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Lathrup Village, Michigan, Forenede Stater, 48076
- Revive Research Institute
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Troy, Michigan, Forenede Stater, 48085-5524
- Oakland Medical Research Center
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine in St. Louis
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Nebraska
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Bellevue, Nebraska, Forenede Stater, 68123-4318
- Nebraska Medical Research Institute, Inc. - CRN
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89104-3953
- Machuca Family Medicine
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Reno, Nevada, Forenede Stater, 89502-1576
- Renown Regional Medical Center Hospital
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New Jersey
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Marlton, New Jersey, Forenede Stater, 08053
- Hassman Research Institute - HRI - Berlin - CenExel - PPDS
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New York
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New York, New York, Forenede Stater, 10017-4008
- AES - DRS - Synexus Clinical Research US, Inc. - New York
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North Carolina
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Denver, North Carolina, Forenede Stater, 28037-7929
- Research Carolina Elite
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Greensboro, North Carolina, Forenede Stater, 27403
- PulmonIx LLC
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Huntersville, North Carolina, Forenede Stater, 28078
- Advanced Respiratory and Sleep Medicine, PLLC
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Winston-Salem, North Carolina, Forenede Stater, 27103-4029
- Southeastern Research Center
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Oklahoma
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Edmond, Oklahoma, Forenede Stater, 73034-3258
- OK Clinical Research
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Oregon
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Portland, Oregon, Forenede Stater, 97213
- The Oregon Clinic
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Pennsylvania
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Altoona, Pennsylvania, Forenede Stater, 16602
- Clinical Research Associates Of Central Pa , Llc
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Pittsburgh, Pennsylvania, Forenede Stater, 15241
- Allergy & Clinical Immun Assoc
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29204
- Medtrial, LLC
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Gaffney, South Carolina, Forenede Stater, 29340-4737
- Velocity Clinical Research - Gaffney - PPDS
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37421
- ClinSearch, LLC
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Franklin, Tennessee, Forenede Stater, 37067-5603
- Clinical Trials Center of Middle Tennessee
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Hendersonville, Tennessee, Forenede Stater, 37075-3085
- Tennessee Comprehensive Lung & Sleep Center
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Texas
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Boerne, Texas, Forenede Stater, 78006
- TTS Research
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Corsicana, Texas, Forenede Stater, 75110-2471
- Corsicana Medical Research
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine Medical Center
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Houston, Texas, Forenede Stater, 77008
- Trio Clinical Trials
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Houston, Texas, Forenede Stater, 77084
- Biopharma Informatic - Park Row - PPDS
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Katy, Texas, Forenede Stater, 77494-2031
- R & H Clinical Research
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Vermont
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Burlington, Vermont, Forenede Stater, 05401
- University of Vermont Medical Center
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Washington
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Everett, Washington, Forenede Stater, 98208
- Western Washington Medical Group
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Wisconsin
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Greenfield, Wisconsin, Forenede Stater, 53228-3467
- Allergy Asthma and Sinus Center-Greenfield
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Amiens, Frankrig, 80090
- Sas Clinique De L Europe - Amiens
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Lille, Frankrig, 59000
- Hopital Calmette
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Paris, Frankrig, 75014
- Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon
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Pessac, Frankrig, 33604
- Hôpital Haut Levêque
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Athens, Grækenland, 106 76
- Evangelismos General Hospital of Athens
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Athens, Grækenland, 115 21
- Navy Hospital of Athens
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Heraklio, Grækenland, 711 10
- University General Hospital of Heraklion
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Ioannina, Grækenland, 455 00
- University General Hospital of Ioannina
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Palaió Fáliro, Grækenland, 175 62
- Iatriko Palaiou Falirou
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Thessaloniki, Grækenland, 570 10
- Georgios Papanikolaou General Hospital of Thessaloniki
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Amersfoort, Holland, 3813 TZ
- Meander Medisch Centrum
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Groningen, Holland, 9728 MG
- Martini Ziekenhuis
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Heerlen, Holland, 6419PC
- Zuyderland Medisch Centrum - Heerlen
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, Indien, 500018
- Paarthiv Lung Care Center
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Hyderabad, Andhra Pradesh, Indien, 500084
- Yashoda Hospitals Hitec City
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Gujarat
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Ahmedabad, Gujarat, Indien, 380059
- GMERS Medical College and Hospital, Sola
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Haryana
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Faridabad, Haryana, Indien, 121012
- ESIC Medical College and Hospital - Faridabad
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Karnataka
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Hubballi, Karnataka, Indien, 580021
- Karnataka Medical College and Research Institute, Hubballi;Department of Medicine
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Maharashtra
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Nagpur, Maharashtra, Indien, 044009
- Shree Hospital And Critical Care Centre
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Pune, Maharashtra, Indien, 411038
- Kothrud Hospital
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Rajasthan
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Jaipur, Rajasthan, Indien, 302004
- Sawai Man Singh Hospital and Medical College
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Jaipur, Rajasthan, Indien, 302039
- Maharaja Agrasen Super Speciality Hospital
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Uttar Pradesh
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Aligarh, Uttar Pradesh, Indien, 202002
- Jawaharlal Nehru Medical College (JNMC)
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Kanpur, Uttar Pradesh, Indien, 208001
- Apollo Spectra Hospital
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Lucknow, Uttar Pradesh, Indien, 226003
- MV Hospital and Research Centre
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Beersheba, Israel, 8410101
- Soroka University Medical Centre
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Haifa, Israel, 3436212
- Lady Davis Carmel Medical Center
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Haifa, Israel, 3109601
- Rambam Medical Center - PPDS
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Jerusalem, Israel, 9112001
- Hadassah Medical Center
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Kfar Saba, Israel, 4428164
- Meir Medical Center
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Campania
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Battipaglia, Campania, Italien, 84091
- Presidio Ospedaliero Santa Maria della Speranza
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Naples, Campania, Italien, 80131
- Azienda Ospedaliera dei Colli
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Emilia-Romagna
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Ferrara, Emilia-Romagna, Italien, 44121
- Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
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Lombardy
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Pavia, Lombardy, Italien, 27100
- Fondazione IRCCS Policlinico San Matteo di Pavia
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Sicily
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Catania, Sicily, Italien, 95123
- Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
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Palermo, Sicily, Italien, 90127
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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Asahikawa-shi, Japan, 070-0901
- Asahikawa Medical Center
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Chikushino-shi, Japan, 818-8502
- Fukuoka University Chikushi Hospital
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Chuo-ku, Fukuoka-shi, Japan, 810-8563
- National Hospital Organization Kyushu Medical Center
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Chūōku, Japan, 104-0031
- Fukuwa Clinic
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Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
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Fukuoka-Shi Nishi-Ku, Japan, 819-0055
- Nishi Fukuoka Hospital
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Himeji, Japan, 670-0849
- Terada Respiratory and Internal Clinic
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Hiroshima, Japan, 734-8530
- Hiroshima Prefectural Hospital
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Ishikawa, Japan, 920-8530
- Ishikawa Prefectural Central Hospital
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Jōyō, Japan, 610-0113
- National Hospital Organization Minami Kyoto Hospital
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Kagoshima, Japan, 890-8520
- Kagoshima University Hospital
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Kagoshima, Japan, 890-0062
- Kagoshima Kouseiren Hospital
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Kanagawa, Japan, 232-0024
- Yokohama City University Medical Center
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Kawachinagano-Shi, Japan, 586-8521
- Osaka-Minami Medical Center
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Kiryū, Japan, 376-0024
- Kiryu Kosei General Hospital
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Kishiwada, Japan, 596-0822
- Kishiwada City Hospital
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Kitakyushu-shi, Japan, 807-8556
- Hospital of the University of Occupational and Environmental Health,Japan
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Kumamoto, Japan, 861-4101
- Saiseikai Kumamoto Hospital
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Kyoto, Japan, 607-8062
- Rakuwakai Otowa Hospital
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Kyoto, Japan, 612-8555
- National Hospital Organization Kyoto Medical Center
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Kōtō City, Japan, 136-0075
- Juntendo Tokyo Koto Geriatric Medical Center
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Machida-shi, Japan, 194-0023
- Machida Municipal Hospital
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Mibu-Machi, Japan, 321-0293
- Dokkyo Medical University Hospital
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Miyagi, Japan, 960-1295
- Fukushima Medical University Hospital
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Nagoya, Japan, 454-8502
- Nagoya Ekisaikai Hospital
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Nagoya-shi Minami-ku, Japan, 457-8511
- Kojunkai Social Medical Corporation Daido Clinic
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Naka-gun, Japan, 319-1113
- National Hospital Organization Ibarakihigashi National Hospital
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Niigata, Japan, 950-11977
- Niigata City General Hospital
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Okayama, Japan, 701-1192
- National Hospital Organization Okayama Medical Center
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Okayama-Shi Minami-ku, Japan, 702-8055
- Okayama Rosai Hospital
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Omuta, Japan, 837-0911
- Omuta National Hospital
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Osaka, Japan, 594-0073
- Izumi City General Hospital
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Sagamihara-shi Minami-ku, Japan, 252-0392
- National Hospital Organization - Sagamihara National Hospital
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Sakaidechō, Japan, 762-0043
- Sakaide City Hospital
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Sakaishi, Japan, 591-8555
- NHO Kinki-Chuo Chest Medical Center
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Sapporo, Japan, 062-8618
- Japan Community Health care Organization Hokkaido Hospital
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Sapporo-shi Chuo-ku, Japan, 064-0804
- Idaimae Minami 4-Jo Internal Medicine
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Shizuoka, Japan, 424-0911
- Shizuoka City Shizuoka Hospital
-
Shizuoka, Japan, 438?8550
- Iwata City Hospital
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Takamatsu, Japan, 761-8073
- Kamei Internal medicine and Respiratory Clinic
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Takasaki, Japan, 370-0829
- National Hospital Organization Takasaki General Medical Center
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Tanabe, Japan, 646-8558
- Minami Wakayama Medical Center
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Tokyo, Japan, 103-0027
- Tokyo-Eki Center-building Clinic
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Tokyo, Japan, 173-8610
- Nihon University Itabashi Hospital
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Tokyo, Japan
- Japanese Red Cross Medical Center
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Toyama, Japan, 930-8550
- Toyama Prefectural Central Hospital
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Yamagata, Japan, 990-9585
- Yamagata University Hospital
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Yanagawa, Japan, 832-0059
- Nagata Hospital
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Yokohama-Shi Totsuka-Ku, Japan, 245-8575
- National Hospital Organization - Yokohama Medical Center
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Yokohama-shi Aoba-ku, Japan, 227-8501
- Showa University Fujigaoka Hospital
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Yokohama-shi Kanazawa-ku, Japan, 236-0051
- Kanagawa Cardiovascular and Respiratory Center
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Yonezawa, Japan, 992-0033
- Sanyudo Hospital
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Ōita, Japan, 870-0263
- Oita Medical Center
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Hokkaido
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Sapporo, Hokkaido, Japan, 001-0901
- Makita Hospital
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Kanagawa
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Miura-shi, Kanagawa, Japan, 238-0111
- Miura Medical Clinic
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Sagamihara-shi, Kanagawa, Japan, 252-0375
- Kitasato University Hospital
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Yokohama, Kanagawa, Japan, 221-0835
- Yokohama Front Clinic
-
Yokohama, Kanagawa, Japan, 232-0066
- Yokohama-Gumyouji Kokyuukinaika Naika Clinic
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Mie-ken
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Matsusaka-Shi, Mie-ken, Japan, 515-8544
- Matsusaka City Hospital
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Okinawa
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Ginowan-shi, Okinawa, Japan, 901-2725
- University of the Ryukyus Hospital
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Shizuoka
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Fujieda-Shi, Shizuoka, Japan, 426-8677
- Fujieda Municipal General Hospital
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Yamaguchi
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Ube-shi, Yamaguchi, Japan, 755-8505
- Yamaguchi University Hospital
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Machakos, Kenya, 90100
- Clinical Research Health Network (CREA-N)
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Nairobi, Kenya, 00100
- KEMRI CRDR Clinical Research Clinic Nairobi
-
Nairobi, Kenya
- University of Nairobi Clinical Research Centre
-
Thika, Kenya, 01000
- Center for Research In Tropical Medicine and community development
-
-
Coast
-
Kilifi, Coast, Kenya, 80108
- KEMRI-MTWAPA Clinical Trial Site
-
-
-
-
-
Beijing, Kina, 100730
- Beijing Hospital
-
Beijing, Kina, 100029
- China-Japan Friendship Hospital
-
Beijing, Kina
- Peking University Shougang Hospital
-
Beijing, Kina, 100020
- Beijing Chaoyang Hospital Capital Medical University
-
Beijing, Kina, 100042
- Beijing Jingmei Group General Hospital
-
Changchun, Kina, 130021
- The First Hospital of Jilin University
-
Changsha, Kina, 410005
- The First Hospital of Changsha
-
Changsha, Kina
- The Third Hospital of Changsha
-
Chengdu, Kina, 610041
- West China Hospital, Sichuan University
-
Chengdu, Kina, 611130
- Chengdu Fifth People's Hospital
-
Chongqing, Kina, 400042
- Army Medical Center of PLA(Daping Hospital)
-
Chongqing, Kina, 400038
- The Southwest Hospital of Army Medical University
-
Guangzhou, Kina, 510180
- Guangzhou First People's Hospital
-
Hangzhou, Kina, 310006
- Hangzhou First People's Hospital
-
Hefei, Kina, 230022
- Anhui Chest Hospital
-
Huizhou, Kina, 516001
- Huizhou Central People's Hospital
-
Linhai, Kina, 317000
- Taizhou Hospital of Zhejiang Province
-
Nanchang, Kina, 330006
- Jiangxi Provincial People's Hospital
-
Nanjing, Kina, 210009
- Zhongda Hospital Southeast University
-
Pingxiang, Kina, 337055
- Jiangxi Pingxiang People's Hospital
-
Shanghai, Kina, 200000
- Huadong Hospital Affiliated to Fudan University
-
Shenyang, Kina, 110004
- Shengjing Hospital of China Medical University
-
Tianjin, Kina, 300052
- Tianjin Medical University General Hospital
-
Wuhan, Kina
- Central Hospital of Wuhan
-
Wuxi, Kina, 214023
- Wuxi People's Hospital
-
Wuxi, Kina, 214400
- Jiangyin People's Hospital
-
Xi'an, Kina, 710100
- Xi'an International Medical Center Hospital
-
Xiamen, Kina, 361004
- Zhongshan Hospital Xiamen University
-
Xinxiang, Kina, 453000
- Xinxiang First People's Hospital
-
Xuzhou, Kina
- The Affiliated Hospital of Xuzhou Medical University
-
Yangzhou, Kina, 225001
- Yangzhou First People?s Hospital
-
Zhuhai, Kina, 519001
- The Fifth Affiliated Hospital Sun Yat-Sen University
-
Zigong, Kina, 643036
- Zigong First People's Hospital
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510150
- The Third Affiliated Hospital of Guangzhou Medical University
-
Guangzhou, Guangdong, Kina, 510160
- The First Affiliated Hospital of Guangzhou Medical University
-
Zhanjiang, Guangdong, Kina, 524001
- Affiliated Hospital of Guangdong Medical University
-
-
Guizhou
-
Zunyi, Guizhou, Kina, 563000
- Affiliated Hospital Of Zunyi Medical University
-
-
Jiangsu
-
Lianyungang, Jiangsu, Kina, 222061
- The First People's Hospital of Lian Yun Gang
-
-
-
-
-
Daugavpils, Letland, LV-5417
- Daugavpils Regional Hospital
-
R?ga, Letland, LV-1002
- Pauls Stradins Clinical University Hospital
-
Riga, Letland, LV-1001
- Riga 1st Hospital
-
Riga, Letland, LV-1010
- ConsiliumMedicum
-
Riga, Letland, LV-1011
- Postgraduate Medical Training Institute University of Latvia
-
-
-
-
-
Auckland, New Zealand, 1051
- Greenlane Clinical Centre
-
Dunedin, New Zealand, 9016
- Dunedin Hospital
-
Hamilton, New Zealand, 3248
- Waikato Hospital
-
Waikanae Beach, New Zealand, 05036
- P3 Research - Kapiti - PPDS
-
-
-
-
-
Bia?ystok, Polen, 15-044
- Centrum Medycyny Oddechowej Mroz sp. j.
-
Bydgoszcz, Polen, 85-079
- Vitamed Galaj I Cichomski sp.j.
-
Bydgoszcz, Polen, 85-231
- Medical Center Kermed
-
Chojnice, Polen, 89-600
- Centrum Medyczne Lukamed Joanna Luka-Wendrowska
-
Gdynia, Polen, 81-537
- Synexus Polska Sp. z o.o. Oddzial w Gdyni
-
Grudzadz, Polen, 86-300
- Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska
-
Grudziądz, Polen, 86-300
- Prywatny Gabinet Pulmonologiczny Joanna Nowacka-Apiyo
-
Katowice, Polen, 40-081
- Centrum Medyczne Katowice - PRATIA - PPDS
-
Ksawerów, Polen, 95-054
- Prywatna Praktyka Lekarska Adam Smialowski
-
Lodz, Polen, 90-127
- AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
-
Lublin, Polen, 20-078
- Clinical Best Solutions - Lublin
-
Lublin, Polen, 20-089
- NZOZ Przychodnia Alergologiczno-pulmonologiczna
-
Radom, Polen, 26-600
- ABC-Pulmo NZOZ Agnieszka Dobielska, Jaroslaw Dobie
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Sopot, Polen, 81-741
- Centrum Medyczne KARDIOTEL
-
Sosnowiec, Polen, 41-200
- Kiepury Clinic
-
Szczecin, Polen, 70-111
- Gabinet Pulmonologii i Diagnostyki Chorob Alergicznych Dorota Malosek
-
Słupsk, Polen, 76-200
- NZOZ Poradnia Chorob Pluc i Alergologii
-
Trzebnica, Polen, 55-100
- Viltis Medica Specjalistyczna Praktyka Lekarska Lek. Med. Agata Kot
-
Warsaw, Polen, 01-192
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
-
Wroc?aw, Polen, 50-381
- Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
-
Wroc?aw, Polen, 51-162
- Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska
-
Wroc?aw, Polen, 54-239
- Lekarze Specjalisci J. Malolepszy i Partnerzy
-
Zabrze, Polen, 41-807
- Medical Center Clinhouse
-
-
Lesser Poland Voivodeship
-
Tarnów, Lesser Poland Voivodeship, Polen, 33-100
- CenterMed Sp. z o.o.
-
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Lódzkie
-
Lodz, Lódzkie, Polen, 90-349
- Appletreeclinics Network Sp. z o.o.
-
-
-
-
-
Guaynabo, Puerto Rico, 00968
- Allianze Pulmonary Research LLC
-
-
-
-
-
Zurich, Schweiz
- Zurcher Reha Zentren Wald
-
-
-
-
-
Barcelona, Spanien, 8041
- Hospital Universitario La Paz - PPDS
-
Seville, Spanien, 41013
- Hospital Universitario Virgen del Rocío
-
Valencia, Spanien, 46010
- Hospital Clinico Universitario de Valencia
-
Valencia, Spanien, 46600
- Hospital de la Ribera
-
-
Balearic Islands
-
Palma de Mallorca, Balearic Islands, Spanien, 07010
- Hospital Universitario Son Espases
-
-
LEON
-
Ponferrada, LEON, Spanien, 24411
- Hospital El Bierzo
-
-
Madrid
-
Torrejón de Ardoz, Madrid, Spanien, 28850
- Hospital Universitario De Torrejon
-
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Malaga
-
Benalmádena Costa, Malaga, Spanien, 29630
- Vithas Xanit International Hospital
-
-
-
-
-
Gothenburg, Sverige, 413 45
- Sahlgrenska Universitetssjukhuset
-
Stockholm, Sverige, 117 27
- Akardo AB
-
-
Uppsala County
-
Uppsala, Uppsala County, Sverige, 752 37
- Clinical Trial Consultants - Linkoping
-
-
-
-
-
Centurion, Sydafrika, 1692
- Johese Clinical Research
-
City of Cape Town, Sydafrika, 7764
- Dr. Ismail Abdullah Private Practice
-
Kempton Park, Sydafrika, 1619
- CLINRESCO, ARWYP Medical Suites
-
Pretoria, Sydafrika, 0184
- AES - DRS - Synexus Watermeyer Clinical Research Centre
-
Pretoria, Sydafrika, 183
- Medicross Pretoria West, Jongaie Research
-
Somerset West, Sydafrika, 7130
- AES - DRS - Synexus - Helderberg Clinical Research Centre
-
Welkom, Sydafrika, 9459
- Dr Yacoob AK Private Practice
-
-
Free State
-
Bloemfontein, Free State, Sydafrika, 9301
- Iatros International
-
-
Gauteng
-
City of Johannesburg, Gauteng, Sydafrika, Hillbrow 2001
- Newtown Clinical Research Centre
-
-
-
-
-
Bucheon-si, Sydkorea, 420-767
- Soon Chun Hyang University Hospital Bucheon
-
Daegu, Sydkorea, 42415
- Yeungnam University Hospital
-
Gyeonggi-do, Sydkorea, 13496
- CHA Bundang Medical Center
-
Seoul, Sydkorea, 03181
- Kangbuk Samsung Hospital
-
Seoul, Sydkorea, 05505
- Asan Medical Center - PPDS
-
Seoul, Sydkorea, 06351
- Samsung Medical Center - PPDS
-
Seoul, Sydkorea, 06973
- Chung-Ang University Hospital
-
Seoul, Sydkorea, 137-701
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Wŏnju, Sydkorea, 220-701
- Yonsei University Wonju Severance Christian Hospital
-
-
-
-
-
Chang-hua, Taiwan, 500
- Changhua Christian Hospital
-
Kaoshiung City, Taiwan, 807
- Kaohsiung Medical University Hospital
-
New Taipei City, Taiwan, 220
- Far East Memorial Hospital
-
Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
-
Taipei, Taiwan, 11031
- Taipei Medical University Hospital
-
Taipei, Taiwan, 11490
- Tri-Service General Hospital
-
-
-
-
-
Khon Kaen, Thailand, 40002
- Srinagarind Hospital, Khon Kaen University
-
Muang, Thailand, 11000
- Central Chest Institute of Thailand
-
-
-
-
-
Brandýs nad Labem-Stará Boleslav, Tjekkiet, 250 01
- Plicní ambulance MUDr. I. Cierná Peterová s.r.o.
-
Hradec Králové, Tjekkiet, 500 05
- Fakultni nemocnice Hradec Kralove
-
Opava, Tjekkiet, 746 01
- Odborna plicni ambulance Opava s.r.o
-
Prague, Tjekkiet, 110 00
- Ordinace chorob plicních s.r.o.
-
Prague, Tjekkiet, 120 00
- AES - DRS - Synexus Czech s.r.o.
-
Teplice, Tjekkiet, 415 01
- Plicni stredisko Teplice s.r.o.
-
Tábor, Tjekkiet, 390 03
- Nemocnice Tabor, a.s.
-
-
-
-
-
Kirikkale, Tyrkiet (Türkiye), 71100
- Kirikkale Universitesi Tip Fakultesi Hastanesi
-
Rize Merkez, Tyrkiet (Türkiye), 53020
- Rize Recep Tayyip Erdogan University Training and Research Hospital
-
Sarıçam, Tyrkiet (Türkiye), 01250
- Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
-
-
-
-
-
Berlin, Tyskland, 12627
- AES - DRS - Synexus Berlin Research Centre
-
Berlin, Tyskland, 10367
- Praxis fur Kardiologie und Pneumologie Dr. med. Karin Forster
-
Berlin, Tyskland, 12157
- Studienpraxis Berlin-Brandenburg, Berlin
-
Darmstadt, Tyskland, 64283
- Lungenzentrum Darmstadt
-
Frankfurt, Tyskland, 60596
- Universitaetsklinikum Frankfurt
-
Hamburg, Tyskland, 22299
- Praxisgem. Dres. Schmoller und Ehlers
-
Hanover, Tyskland, 30173
- Pneumologicum
-
Heidelberg, Tyskland, 69120
- University Clinic Heidelberg
-
Immenhausen, Tyskland, 34376
- Lungenfachklinik Immenhausen
-
Leipzig, Tyskland, 04299
- BAG Prof. Dr. G. Hoheisel Dr. A. Bonitz
-
Magdeburg, Tyskland, 39120
- SMO.MD GmbH
-
München, Tyskland, 80539
- Praxis Dr. med. Jan Feimer
-
Neu-Isenburg, Tyskland, 63263
- Institut fur klinische Forschung GmbH
-
Rheine, Tyskland, 48431
- Framol-Med GmbH
-
Rosenheim, Tyskland, 83022
- Klinikum Rosenheim
-
-
Schleswig-Holstein
-
Lübeck, Schleswig-Holstein, Tyskland, 23552
- Velocity Clinical Research Leipzig GmbH
-
-
-
-
-
Budapest, Ungarn, 1089
- Benyovszky Medical Center
-
Csorna, Ungarn, 9300
- Omnimodus Elixír Kft.
-
-
-
-
-
Feldbach, Østrig, 8330
- Ordination Dr. Robert Voves
-
Linz, Østrig, 4020
- Ordination fur Lungenkrankheiten
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier
- Dokumenteret KOL-diagnose i ≥ 12 måneder
- Anamnese med hyppige eksacerbationer, defineret som at have haft 2 eller flere moderate eller svære KOL-eksacerbationer inden for 12 måneder før screening
- Post-bronkodilatator FEV1 ≥ 20 % og < 80 % af forudsagt ved screening
- Post-bronkodilatator FEV1/FVC < 0,70 ved screening
- Modificeret Medical Research Council (dyspnø-skala) (mMRC) score ≥ 2
- Nuværende tobaksryger eller tidligere ryger med en historie med rygning ≥ 10 pakkeår
- Ved optimeret KOL vedligeholdelsesbehandling som defineret nedenfor i ≥ 12 måneder før screening og stabil på nuværende behandling i mindst 4 uger før screening: Inhaleret kortikosteroid (ICS) plus langtidsvirkende beta-agonist (LABA), langtidsvirkende muskarin antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
- Røntgen af thorax eller computertomografi (CT) scanning inden for 6 måneder før screening eller røntgen af thorax i screeningsperioden, der bekræfter fraværet af klinisk signifikant lungesygdom udover KOL
Eksklusionskriterier
- Aktuel dokumenteret diagnose af astma
- Anamnese med anden klinisk signifikant lungesygdom end KOL
- Diagnose af 1-antitrypsin-mangel
- Anamnese med langtidsbehandling med ilt ved > 4,0 liter/minut
- Operation eller procedure med reduktion af lungevolumen inden for 12 måneder før screening
- Personer, der deltager i eller er planlagt til et intensivt KOL-rehabiliteringsprogram (deltagere, der er i vedligeholdelsesfasen af et rehabiliteringsprogram, er berettigede)
- Historie om lungetransplantation
- Enhver infektion, der resulterede i hospitalsindlæggelse i ≥ 24 timer og/eller behandling med orale, IV eller im-antibiotika inden for 4 uger før eller under screening
- Øvre eller nedre luftvejsinfektion inden for 4 uger før eller under screening
- Behandling med orale, IV eller IM kortikosteroider inden for 4 uger før påbegyndelse af studielægemidlet
- Påbegyndelse af eller ændring i ikke-biologisk immunmodulerende eller immunsuppressiv behandling inden for 3 måneder før screening
- Ustabil hjertesygdom, myokardieinfarkt eller New York Heart Association klasse III eller IV hjertesvigt inden for 12 måneder før screening
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Astegolimab SC Q2W
Deltagerne vil modtage subkutan (SC) astegolimab hver anden uge (Q2W)
|
Deltagerne vil modtage SC astegolimab Q2W eller Q4W
|
|
Eksperimentel: Astegolimab SC Q4W
Deltagerne vil skiftevis modtage SC astegolimab og placebo Q2W og vil således modtage SC astegolimab Q4W.
|
Deltagerne vil modtage SC astegolimab Q2W eller Q4W
|
|
Placebo komparator: Placebo SC Q2W
Deltagerne vil modtage SC placebo Q2W
|
Deltagerne vil modtage SC placebo Q2W
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Årlig rate af moderate og svære KOL-eksacerbationer over den 52-ugers behandlingsperiode
Tidsramme: 52 uger
|
52 uger
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Tid til den første moderate eller svære KOL-eksacerbation i den 52-ugers behandlingsperiode
Tidsramme: 52 uger
|
52 uger
|
|
Absolut ændring fra baseline i sundhedsrelateret livskvalitet (HRQoL) i uge 52 som vurderet gennem St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score
Tidsramme: Uge 52
|
Uge 52
|
|
Absolut ændring fra baseline i post-bronkodilatator forceret eksspiratorisk volumen (FEV1) i uge 52
Tidsramme: Uge 52
|
Uge 52
|
|
Absolut ændring fra baseline i Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) totalscore ved uge 52
Tidsramme: Uge 52
|
Uge 52
|
|
Andel af deltagere med forbedring af HRQoL i uge 52
Tidsramme: Uge 52
|
Uge 52
|
|
Årlig frekvens af alvorlige KOL-eksacerbationer over den 52-ugers behandlingsperiode
Tidsramme: 52 uger
|
52 uger
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Papi A, Greening NJ, Bhatt SP, Roche N, Celli B, Wedzicha JA, Agusti A, Tal-Singer R, Han MK, Janssens W, Hanania NA, Nair P, Bremner P, Porpodis K, Shibata Y, Korn S, Yang T, Gordon O, Saenz R, Ng J, Cheung DS, Devine J, Grimbaldeston MA, Zhang W, Yang X, Mohan D, Vogelmeier CF, Brightling CE; ALIENTO and ARNASA investigators. Safety and efficacy of astegolimab for COPD with frequent exacerbations regardless of baseline blood eosinophil counts (ALIENTO and ARNASA): randomised, double-blind, placebo-controlled, phase 2b and 3 trials. Lancet. 2026 May 18:S0140-6736(26)00637-9. doi: 10.1016/S0140-6736(26)00637-9. Online ahead of print.
- Wedzicha JA, Agusti A, Brightling CE, Calverley P, Chalmers JD, Greening NJ, Han MK, Mohan D, Ng J, Papi A, Roche N, Saenz R, Samara K, Tal-Singer R, Vogelmeier CF, Yang X, Celli BR. Astegolimab for COPD With Frequent Exacerbations: Pooled Analysis of the ALIENTO and ARNASA Trials. Am J Respir Crit Care Med. 2026 May 18:aamag226. doi: 10.1093/ajrccm/aamag226. Online ahead of print.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
29. december 2022
Primær færdiggørelse (Faktiske)
24. juni 2025
Studieafslutning (Anslået)
24. september 2027
Datoer for studieregistrering
Først indsendt
24. oktober 2022
Først indsendt, der opfyldte QC-kriterier
24. oktober 2022
Først opslået (Faktiske)
27. oktober 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GB44332
- 2022-502234-70-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Kvalificerede forskere kan anmode om adgang til data på individuelt patientniveau via platformen for anmodninger om kliniske undersøgelsesdata (www.vivli.org).
Yderligere detaljer om Roches kriterier for kvalificerede undersøgelser er tilgængelige her (https://vivli.org/ourmember/roche/).
For yderligere detaljer om Roches globale politik om deling af klinisk information og hvordan man anmoder om adgang til relaterede kliniske undersøgelsesdokumenter, se her (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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