특발성 폐섬유증에 대한 Bexotegrast(PLN-74809)의 효능 및 안전성에 대한 무작위 이중 맹검 연구
2026년 8월 3일 업데이트: Pliant Therapeutics, Inc.
특발성 폐섬유증(BEACON-IPF) 치료를 위한 Bexotegrast(PLN-74809)의 효능과 안전성을 평가하기 위한 무작위, 이중 맹검, 용량 범위, 위약 대조 연구
특발성 폐섬유증(BEACON-IPF) 치료를 위한 벡소테그라스트(PLN-74809)의 효능과 안전성을 평가하기 위한 무작위, 이중 맹검, 용량 범위, 위약 대조 연구입니다.
연구 개요
상세 설명
이는 IPF를 복용한 참가자와 그렇지 않은 참가자가 52주 동안 복용한 2가지 용량의 벡소테그라스트(PLN-74809)[160mg 및 320mg]의 효능과 안전성을 평가하기 위한 무작위, 이중 맹검, 용량 범위, 위약 대조 연구입니다. 배경 요법(즉, 닌테다닙 또는 피르페니돈)을 복용합니다.
연구는 최대 28일의 스크리닝 기간, 52주 치료 기간 및 14일 안전성 추적 기간으로 구성됩니다. 참고로, 연구 시작 시 배경 치료를 받지 않은 참가자는 연구 중 언제든지 이를 시작할 수 있습니다.
연구 유형
중재적
등록 (실제)
320
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Heraklion, 그리스, 71110
- University General Hospital of Heraklion
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Achaïa
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Pátrai, Achaïa, 그리스, 265 04
- University General Hospital of Patras
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Attica
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Athens, Attica, 그리스, 115 27
- Sotiria Thoracic Diseases Hospital of Athens
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Evros
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Alexandroupoli, Evros, 그리스, 681 00
- University General Hospital of Alexandroupolis
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North Holland
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Amsterdam, North Holland, 네덜란드, 1081 HV
- VU Medisch Centrum
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Utrecht
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Nieuwegein, Utrecht, 네덜란드
- St. Antonius Ziekenhuis
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Canterbury
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Christchurch, Canterbury, 뉴질랜드, 8013
- Christchurch Hospital
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North Island
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Auckland, North Island, 뉴질랜드, 1051
- Greenlane Clinical Centre
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Otago
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Dunedin, Otago, 뉴질랜드, 9016
- Dunedin Hospital
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Waikato Region
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Hamilton, Waikato Region, 뉴질랜드, 3204
- Waikato Hospital
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Kaohsiung City, 대만, 807
- Kaohsiung Medical University - Chung-Ho Memorial Hospital
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Taichung, 대만, 40447
- China Medical University Hospital
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Taichung, 대만
- Taichung Veterans General Hospital
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Taipei, 대만, 10002
- National Taiwan University Hospital
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Taipei, 대만, 11217
- Taipei Veterans General Hospital
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Taipei, 대만, 220
- Far Eastern Memorial Hospital
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Busan, 대한민국, 48108
- Inje University Haeundae Paik Hospital
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Seoul, 대한민국, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, 대한민국, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Gyeongsangnam-do
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Pusan, Gyeongsangnam-do, 대한민국, 50834
- Inje University Busan Paik Hospital
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, 대한민국, 02841
- Korea University Anam Hospital
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Seoul, Seoul Teugbyeolsi, 대한민국, 04763
- Hanyang University Medical Center
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Aarhus, 덴마크, 8200
- Aarhus Universitetshospital
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Aarhus, 덴마크
- Aarhus Universitetshospital
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Hellerup, 덴마크, 2900
- Gentofte Hospital
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Odense, 덴마크
- Odense Universitetshospital
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Region Syddanmark
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Odense, Region Syddanmark, 덴마크, 5000
- Odense Universitetshospital
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Coswig, 독일, 01640
- Fachkrankenhaus Coswig GmbH
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Frankfurt, 독일
- IKF Pneumologie GmbH & Co. KG
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Homburg, 독일
- Universitaetsklinikum des Saarlandes
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Leipzig, 독일
- Universitaetsklinikum Leipzig AoeR
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Bavaria
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München, Bavaria, 독일, 81377
- LMU Klinikum der Universität München - Campus Großhadern
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Lower Saxony
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Hanover, Lower Saxony, 독일, 30625
- Medizinische Hochschule Hannover
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North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, 독일, 51109
- Kliniken der Stadt Köln
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Essen, North Rhine-Westphalia, 독일, 45239
- Ruhrlandklinik
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, 독일, 24105
- Universitätsklinikum Schleswig-Holstein, Campus Kiel
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State of Berlin
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Berlin, State of Berlin, 독일, 13125
- Evangelische Lungenklinik Berlin
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
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Arizona
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Phoenix, Arizona, 미국, 85012
- Arizona Pulmonary Specialists
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Phoenix, Arizona, 미국, 85013
- Dignity Health-St. Josephs Hospital and Medical Center
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Tucson, Arizona, 미국, 85724
- Banner University Medical Center
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California
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Los Angeles, California, 미국, 90048
- Cedars Sinai Medical Center
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New Port Beach, California, 미국, 92663
- Newport Native MD, Inc
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Palm Springs, California, 미국, 92262
- Palmtree Clinical Research
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Palo Alto, California, 미국, 94304
- VA Palo Alto Health Care System
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Redding, California, 미국, 96001
- Paradigm Clinical Research Institute Inc - ClinEdge
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Sacramento, California, 미국, 95807
- University of California Davis Comprehensive Cancer Center
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San Francisco, California, 미국, 94143
- UCSF Medical Center - Pulmonary Practice
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Santa Barbara, California, 미국, 93105
- Jeffrey S. Sager, MD Medical Corporation
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Stanford, California, 미국, 94305
- Stanford Health Care
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Colorado
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Aurora, Colorado, 미국, 80048
- University of Colorado
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Denver, Colorado, 미국, 80206
- National Jewish Health Main Campus
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Lakewood, Colorado, 미국, 80228
- Critical Care, Pulmonary and Sleep Associates
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Connecticut
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Danbury, Connecticut, 미국, 06810
- Nuvance Health Medical Practices, Pulmonary & Sleep Specialists
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New Haven, Connecticut, 미국, 06510
- Yale New Haven Hospital - York Street Campus
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20007
- MedStar Georgetown University Hospital
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Florida
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Gainesville, Florida, 미국, 32608
- Malcom Randall VA Medical Center
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Jacksonville, Florida, 미국, 32224
- Mayo Clinic Jacksonville
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Kissimmee, Florida, 미국, 34746
- Clinical Research Specialists, LLC
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Leesburg, Florida, 미국, 34738
- Clinical Site Partners - Leesburg
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Orlando, Florida, 미국, 32803
- Central Florida Pulmonary Group PA
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Tampa, Florida, 미국, 33609
- GCP Clinical Research
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory Clinic
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Augusta, Georgia, 미국, 30912
- Augusta University
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern Memorial Hospital
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Maywood, Illinois, 미국, 60153
- Loyola University Medical Center
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Indiana
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Indianapolis, Indiana, 미국, 46202
- IU Health Advanced Heart and Lung Care
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center
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Kentucky
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Lexington, Kentucky, 미국, 40508
- Lexington VA Medical Center
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Louisville, Kentucky, 미국, 40202
- Norton Pulmonary Specialists
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- Tulane Medical Center
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Maryland
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Baltimore, Maryland, 미국, 21201
- University of Maryland Medical Center
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Baltimore, Maryland, 미국, 21224
- The Johns Hopkins Hospital JHH
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess Medical Cente
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Boston, Massachusetts, 미국, 02115
- Brigham and Womans Hospital
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital - Pulmonary Associates
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North Dartmouth, Massachusetts, 미국, 02747
- Infinity Medical Research
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan Health System
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Detroit, Michigan, 미국, 48202
- Henry Ford Health System
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- University of Minnesota Medical Center, Fairview
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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Missouri
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Chesterfield, Missouri, 미국, 63017
- The Lung Research Center
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756
- Dartmouth Hitchcock Medical Center
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New York
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New York, New York, 미국, 10029
- Icahn School Of Medicine At Mount Sinai
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New York, New York, 미국, 10032
- New York Presbyterian Hospital-Columbia University Medical Center
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New York, New York, 미국, 10032
- Weill Cornell Medicine
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The Bronx, New York, 미국, 10467
- Montefiore Medical Center Moses Division Hospital
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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Greensboro, North Carolina, 미국, 27403
- PulmonIx, LLC
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Winston-Salem, North Carolina, 미국, 27103
- Southeastern Research Center
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Ohio
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Cincinnati, Ohio, 미국, 45267
- University of Cincinnati
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Cleveland, Ohio, 미국, 44195
- The Cleveland Clinic Foundation
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- OU Health Physicians
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Oregon
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Bend, Oregon, 미국, 97701
- Bend Memorial Clinic/Summit Medical Group - Eastside
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Portland, Oregon, 미국, 97232
- Legacy Good Samaritan Hospital
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Pennsylvania
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DuBois, Pennsylvania, 미국, 15801
- Clinical Research Associates Of Central Pa , Llc
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Hershey, Pennsylvania, 미국, 17033
- Penn State Health Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, 미국, 19104
- Perelman Center for Advanced Medicine
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Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh Medical Center
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South Carolina
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Charleston, South Carolina, 미국, 29425
- Medical University of South Carolina
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Greenville, South Carolina, 미국, 29615
- Velocity Clinical Research
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North Charleston, South Carolina, 미국, 29406
- Lowcountry Lung and Critical Care PA
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Tennessee
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Franklin, Tennessee, 미국, 37067
- Clinical Trials Center of Middle Tennessee
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Knoxville, Tennessee, 미국, 37920
- University of Tennessee Medical Center
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Knoxville, Tennessee, 미국, 37909
- Statcare Pulmonary Consultants - Knoxville
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Nashville, Tennessee, 미국, 37204
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, 미국, 75246
- Baylor Scott and White Health - Advanced Lung Disease Specialists
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El Paso, Texas, 미국, 79902
- El Paso Pulmonary Association
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Houston, Texas, 미국, 77030
- Baylor College of Medicine
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McKinney, Texas, 미국, 75071
- Research Centers of America
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The Woodlands, Texas, 미국, 77380
- Renovatio Clinical Research
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Waxahachie, Texas, 미국, 75165
- Topline Clinical Research
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Utah
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Salt Lake City, Utah, 미국, 84108
- University of Utah
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Vermont
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Burlington, Vermont, 미국, 05401
- University of Vermont Medical Center
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Virginia
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Falls Church, Virginia, 미국, 22042
- Inova Fairfax Medical Campus
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Washington
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Everett, Washington, 미국, 98208
- Western Washington Medical Group
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Leuven, 벨기에, 3000
- UZ Leuvan
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West-Vlaanderen
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Roeselare, West-Vlaanderen, 벨기에, 8800
- AZ Delta
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Porto Alegre, 브라질, 90610-000
- Hospital Sao Lucas da PUCRS
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Porto Alegre, 브라질, 90410-001
- Hospital de Clinicas de Porto Alegre HCPA - PPDS
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Estado de Bahia
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Salvador, Estado de Bahia, 브라질, 40170310
- Hospital Cardio Pulmonar
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Minas Gerais
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Belo Horizonte, Minas Gerais, 브라질, 30150-221
- Santa Casa de Misericordia de Belo Horizonte
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Rio Grande do Sul
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Passo Fundo, Rio Grande do Sul, 브라질, 99010-120
- Instituto Méderi de Pesquisa e Saúde
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Porto Alegre, Rio Grande do Sul, 브라질, 90050-170
- Irmandade da Santa Casa de Misericordia de Porto Alegre
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Porto Alegre, Rio Grande do Sul, 브라질, 90160-093
- Hospital Ernesto Dornelles
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Porto Alegre, Rio Grande do Sul, 브라질, 91010-006
- Hospital Nossa Senhora da Conceicao
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Majadahonda, 스페인
- Hospital Universitario Puerta de Hierro Majadahonda
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Málaga, 스페인
- Hospital Clinico Universitario Virgen de la Victoria
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Santiago de Compostela, 스페인, 15706
- CHUS - H. Clinico U. de Santiago
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Barcelona
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Barcelona, Barcelona, 스페인, 08907
- Hospital Universitari de Bellvitge
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Madrid
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Majadahonda, Madrid, 스페인, 28222
- Hospital Universitario Puerta de Hierro - Majadahonda
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Córdoba, 아르헨티나, X5003DCE
- Instituto de Medicina Respiratoria
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Buenos Aires
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Mar del Plata, Buenos Aires, 아르헨티나, 7600
- Centro de Investigaciones Medicas Mar del Plata
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Mar del Plata, Buenos Aires, 아르헨티나, B7600DCK
- Instituto Ave Pulmo
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Munro, Buenos Aires, 아르헨티나, B1605FRE
- Clinica Privada Independencia
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Quilmes, Buenos Aires, 아르헨티나, B1878FNR
- Centro Respiratorio Quilmes
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Vicente López, Buenos Aires, 아르헨티나, 1602
- CEMER - Centro Medico de Enfermedades Respiratorias
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., 아르헨티나, C1425FVH
- Consultorios Medicos Organizacion de Buen Ayre SRL
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Ciudad Autonoma Buenos Aires
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Buenos Aires, Ciudad Autonoma Buenos Aires, 아르헨티나, 1060
- Centro de Investigacion Clinica-CEDIC
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Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires, 아르헨티나, 1280
- Hospital Britanico de Buenos Aires
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Ciudad Autónoma de BuenosAires
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Buenos Aires, Ciudad Autónoma de BuenosAires, 아르헨티나, C1426ABP
- Centro Médico Dra de Salvo
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Mendoza Province
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Mendoza, Mendoza Province, 아르헨티나, M5500AXR
- Fundacion Scherbovsky
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Mendoza, Mendoza Province, 아르헨티나, M5500CCG
- INSARES
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Santa Fe Province
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Rosario, Santa Fe Province, 아르헨티나, 2000
- Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
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Rosario, Santa Fe Province, 아르헨티나, S2000DEJ
- Instituto Medico de la Fundacion Estudios Clinicos
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Rosario, Santa Fe Province, 아르헨티나, S2000DSV
- Sanatorio Parque de Rosario
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, 아르헨티나, T4000CBC
- Centro Integral de Medicina Respiratoria (CIMER)
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Birmingham
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Birmingham, Birmingham, 영국, B9 5SS
- Birmingham Heartlands Hospital
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Cambridgeshire
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Cambridge, Cambridgeshire, 영국, CB2 0AY
- Royal Papworth Hospital
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Peterborough, Cambridgeshire, 영국, PE3 9GZ
- Peterborough City Hospital
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Derry
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Londonderry, Derry, 영국, BT47 6SB
- Altnagelvin Area Hospital
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Hampshire
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Southampton, Hampshire, 영국, SO16 6YD
- Southampton General Hospital
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London
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London, London, 영국, SW3 6NP
- Royal Brompton Hospital
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North Humberside
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Cottingham, North Humberside, 영국, HU16 5JQ
- Castle Hill Hospital
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Oxfordshire
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Oxford, Oxfordshire, 영국, OX3 7LE
- Churchill Hospital
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West Yorkshire
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Wakefield, West Yorkshire, 영국, WF1 4DG
- Pinderfields General Hospital
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-
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Beersheba, 이스라엘, 84001
- Soroka University Medical Center
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Haifa, 이스라엘, 34980
- Rambam Medical Center
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Kfar Saba, 이스라엘, 4428164
- Meir Medical Center
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Petah Tikva, 이스라엘, 49100
- Rabin Medical Center
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Central District
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Rehovot, Central District, 이스라엘, 76100
- Kaplan Medical Center
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Haifa District
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Haifa, Haifa District, 이스라엘, 34362
- Lady Davis Carmel Medical Center
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Jerusalem
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Jerusalem, Jerusalem, 이스라엘, 91031
- Shaare Zedek Medical Center
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Southern District
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Ashkelon, Southern District, 이스라엘, 7830604
- Barzilai Medical Center
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Tel Aviv
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Ashkelon, Tel Aviv, 이스라엘, 78278
- Tel Aviv Sourasky Medical Center
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Ramat Gan, Tel Aviv, 이스라엘, 52394
- Sheba Medical Center
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-
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Alessandria
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Alessandria, Alessandria, 이탈리아, 15121
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
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Bergamo
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Bergamo, Bergamo, 이탈리아, 24127
- ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
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Firenze
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Florence, Firenze, 이탈리아, 50134
- Azienda Ospedaliera Universitaria Careggi
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Foggia
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Foggia, Foggia, 이탈리아, 71122
- Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia
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Milano
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Milan, Milano, 이탈리아, 20123
- Ospedale San Giuseppe Multimedica SpA
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Gujarat
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Surat, Gujarat, 인도, 395010
- Unity Hospital ICU and Trauma
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Haryana
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Faridabad, Haryana, 인도, 121001
- ESIC Medical College and Hospital
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Karnataka
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Belagavi, Karnataka, 인도, 590010
- K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre
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Belagavi, Karnataka, 인도, 590016
- BHS Lakeview Hospital
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Maharashtra
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Mumbai, Maharashtra, 인도, 400007
- Bhatia Hospital
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Nashik, Maharashtra, 인도, 422007
- Siddhi Hospital
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Rajasthan
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Ajmer, Rajasthan, 인도, 305001
- J.L.N., Medical College and Attached Hospitals
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Jaipur, Rajasthan, 인도, 302023
- Asthma Bhavan
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Uttar Pradesh
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Lucknow, Uttar Pradesh, 인도, 226006
- Midland Healthcare & Research Center
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West Bengal
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Kolkata, West Bengal, 인도, 700027
- Calcutta Medical Research Institute
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Kolkata, West Bengal, 인도, 700053
- B. P. Poddar Hospital and Medical Research Limited
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-
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Fukuoka
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Fukuoka, Fukuoka, 일본, 814-0180
- Fukuoka University Hospital
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Fukuoka, Fukuoka, 일본, 810-0066
- NHO Kyushu Medical Center
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Iizuka-shi, Fukuoka, 일본, 820-8505
- Aso Co.,Ltd Iizuka Hospital
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Kitakyushu-shi, Fukuoka, 일본, 807-8556
- Hospital of the University of Occupational and Environmental Health
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Fukushima
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Fukushima, Fukushima, 일본, 960-1295
- Fukushima Medical University Hospital
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Hiroshima
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Hiroshima, Hiroshima, 일본, 732-0827
- Hiroshima Prefectural Hospital
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Hokkaido
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Sapporo, Hokkaido, 일본, 060-0001
- Sapporo Medical University Hospital
-
-
Hyōgo
-
Kobe, Hyōgo, 일본, 650-0047
- Kobe City Hospital Organization
-
Kobe, Hyōgo, 일본, 6500047
- Center General Hospital
-
-
Ibaraki
-
Naka-gun, Ibaraki, 일본, 319-1113
- NHO Ibarakihigashi National Hospital
-
-
Kanagawa
-
Kawasaki-shi, Kanagawa, 일본, 216-8511
- Tokushima University Hospital
-
Yokohama, Kanagawa, 일본, 236-0051
- Kanagawa Cardiovascular and Respiratory Center
-
-
Kumamoto
-
Kumamoto, Kumamoto, 일본, 860-8556
- Kumamoto University Hospital
-
-
Okayama-ken
-
Okayama, Okayama-ken, 일본, 700-8558
- Okayama University Hospital
-
-
Osaka
-
Osaka, Osaka, 일본, 591-8555
- NHO Kinki-Chuo Chest Medical Center
-
-
Saitama
-
Kumagaya-shi, Saitama, 일본, 360-0197
- Saitama Prefectural Cardiovascular and Respiratory Center
-
Saitama-shi, Saitama, 일본, 330-8553
- Saitama Red Cross Hospital
-
-
Shimane
-
Izumo-shi, Shimane, 일본, 693-8501
- Shimane University Hospital
-
-
Shizuoka
-
Hamamatsu, Shizuoka, 일본, 431-3192
- Hamamatsu University School of Medicine, University Hospital
-
-
Tokyo-To
-
Bunkyō City, Tokyo-To, 일본, 113-8519
- Institute of Science Tokyo Hospital
-
Bunkyō City, Tokyo-To, 일본, 113-8603
- Nippon Medical School Hospital
-
Hachioji-shi, Tokyo-To, 일본, 192-0081
- NHO Okinawa National Hospital
-
Minatoku, Tokyo-To, 일본, 105-0023
- Juntendo University Hospital
-
-
-
-
Anhui
-
Hefei, Anhui, 중국, 230061
- The Second Hospital of Anhui Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510515
- Nanfang Hospital of Southern Medical University
-
Guangzhou, Guangdong, 중국, 510163
- The First Affiliated Hospital of Guangzhou Medical University
-
-
Hebei
-
Shijiazhuang, Hebei, 중국, 50051
- The 3rd Hospital of Hebei Medical University
-
-
Henan
-
Zhengzhou, Henan, 중국, 450003
- Henan Provincial People's Hospital
-
Zhengzhou, Henan, 중국, 450000
- Henan Provincial Chest Hospital
-
-
Hubei
-
Yichang, Hubei, 중국, 443000
- Yichang Central People's Hospital
-
-
Hunan
-
Changsha, Hunan, 중국, 410008
- The second Xiangya hospital of central south university
-
-
Jiangsu
-
Wuxi, Jiangsu, 중국, 214023
- Wuxi People's Hospital
-
Xuzhou, Jiangsu, 중국, 221006
- The Affiliated Hospital of Xuzhou Medical College
-
-
Jiangxi
-
Nanchang, Jiangxi, 중국, 330209
- The First Affiliated Hospital Of Nanchang University
-
-
Liaoning
-
Shenyang, Liaoning, 중국, 110004
- Shengjing Hospital of China Medical University
-
-
Shandong
-
Jinan, Shandong, 중국, 250012
- Qilu Hospital of Shandong University
-
-
Sichuan
-
Chengdu, Sichuan, 중국, 610041
- West China Hospital, Sichuan University
-
Chengdu, Sichuan, 중국, 610072
- Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, 중국, 300052
- Tianjin Medical University General Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, 중국, 310006
- Hangzhou First People's Hospital
-
-
-
-
-
Prague, 체코, 140 00
- Fakultni Thomayerova nemocnice
-
-
Olomouc Region
-
Olomouc, Olomouc Region, 체코, 779 00
- Fakultni nemocnice Olomouc
-
-
South Moravian
-
Brno, South Moravian, 체코, 625 00
- Fakultní Nemocnice Brno
-
-
-
-
-
Quillota, 칠레, 2260734
- CENRESIN
-
Santiago, 칠레, 7500571
- Av. Providencia 1208 oficina 209
-
Santiago, 칠레, 7750495
- CEC SpA
-
Santiago, 칠레, 8330336
- Biocinetic
-
Santiago, 칠레, 7500657
- CIMER - Centro de Investigaciones Medicas Respiratorias
-
Talca, 칠레, 3481349
- Centro de Investigacion del Maule
-
-
-
-
British Columbia
-
Kelowna, British Columbia, 캐나다, V1Y 3H5
- Kelowna Respirology and Allergy Research
-
Vancouver, British Columbia, 캐나다, V6Z 1Y6
- Pacific Lung Research Center
-
-
Ontario
-
Ajax, Ontario, 캐나다, L1S 2J5
- Dynamic Drug Advancement
-
-
Quebec
-
Saint-Charles-Borromée, Quebec, 캐나다, J6E 2B4
- CIC Joliette
-
Trois-Rivières, Quebec, 캐나다, G8T 7A1
- Centre d'investigation Clinique Mauricie
-
-
-
-
-
Braga, 포르투갈, 4710-243
- Hospital de Braga
-
Vila Nova de Gaia, 포르투갈, 4434-502
- Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
-
-
Portugal
-
Lisbon, Portugal, 포르투갈, 1169-024
- Centro Hospitalar de Lisboa Central, E.P.E - Hospital de Santa Marta
-
-
-
-
-
Bydgoszcz, 폴란드
- Vitamed Galaj i Cichomski sp.j.
-
Gdansk, 폴란드, 80-952
- Uniwersyteckie Centrum Kliniczne
-
Krakow, 폴란드, 30-688
- SP ZOZ Szpital Uniwersytecki w Krakowie
-
-
Lubusz Voivodeship
-
Nowa Sól, Lubusz Voivodeship, 폴란드, 67-100
- Twoja Przychodnia NCM
-
-
-
-
-
Bordeaux, 프랑스
- CHU de Bordeaux- Hopital du Haut Lévêque
-
Lyon, 프랑스
- CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
-
Marseille, 프랑스
- Hopital Nord - CHU Marseille
-
Montpellier, 프랑스
- CHU Arnaud de Villeneuve
-
Nice, 프랑스
- CHU Nice - Hôpital Pasteur
-
Nice, 프랑스
- Hopital Pasteur CHU Nice
-
Paris, 프랑스
- Hopital Bichat - Claude Bernard
-
Paris, 프랑스
- Hospital Bretonneau
-
Pessac, 프랑스
- Hopital Haut-Leveque Pharmacie
-
Reims, 프랑스
- CHU Reims - Hôpital Maison Blanche
-
Toulouse, 프랑스
- Hopital Larrey
-
-
Ille-et-Vilaine
-
Rennes, Ille-et-Vilaine, 프랑스, 35000
- Hopital Pontchaillou
-
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Nord
-
Lille, Nord, 프랑스, 59037
- Institut Coeur Poumon - CHU de Lille
-
-
Seine St Denis
-
Bobigny, Seine St Denis, 프랑스, 93000
- Hopital Avicenne
-
-
-
-
-
Midland, 호주, 6056
- Institute for Respiratory Health - Midland
-
-
New South Wales
-
Camperdown, New South Wales, 호주, 2050
- Royal Prince Alfred Hospital
-
-
Queensland
-
Chermside, Queensland, 호주, 4032
- Lung Research Qld
-
-
South Australia
-
Kent Town, South Australia, 호주, 5067
- Respiratory Clinical Trials
-
Woodville South, South Australia, 호주, 5011
- The Queen Elizabeth Hospital
-
-
Victoria
-
Box Hill, Victoria, 호주, 3128
- Box Hill Hospital
-
Clayton, Victoria, 호주, 3168
- Monash Medical Centre
-
Heidelberg, Victoria, 호주, 3084
- Austin Health
-
Melbourne, Victoria, 호주, 3004
- The Alfred Hospital
-
-
Western Australia
-
Murdoch, Western Australia, 호주, 6050
- Fiona Stanley Hospital
-
Spearwood, Western Australia, 호주, 6163
- Trialswest
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 검진 전 40세 이상
- IPF 진단 ≤ 스크리닝 전 7년
- FVCpp ≥ 45%
- 일산화탄소 예측 백분율(헤모글로빈 조정)에 대한 확산 용량 ≥ 30% 및 < 90%
- 스크리닝 전 ≥ 12주 동안 안정적인 용량을 사용한 경우 배경 요법을 포함한 IPF에 대한 현재 치료가 허용됩니다.
- 현재 IPF 치료를 받고 있지 않은 경우(치료 경험이 없거나 이전 치료를 중단함), 참가자는 스크리닝 전 최소 8주 동안 배경 치료를 받지 않아야 합니다.
제외 기준:
- 폐고혈압에 대한 약물치료를 받고 있는 경우
- 모든 종류의 흡연을 스스로 신고한 경우(담배에만 국한되지 않음)
- 지난 5년 이내에 악성 종양의 병력이 있거나 기저 세포 암종, 절제된 비침습성 피부 편평 세포 암종 또는 치료된 상피내 자궁 경부 암종 이외의 진행 중인 악성 종양
- 간 장애 또는 말기 간 질환
- 신장 손상 또는 투석이 필요한 말기 신장 질환
- 임신 또는 수유중인 여성 참가자
- 조절되지 않는 전신 동맥 고혈압
- IPF의 섬유증 치료를 위해 승인되지 않았거나 연구 중인 약제를 받은 경우
- 벡소테그라스트 사전 투여
- 연구 기간 동안 폐 이식을 받을 가능성이 있음(이식 목록에 있는 것도 제외되지 않음)
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: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 위약
|
위약
|
|
실험적: 벡소테그라스트(PLN-74809) 160mg 용량
벡소테그라스트(PLN-74809) 160mg 용량 - 52주
|
PLN-74809
|
|
실험적: 벡소테그라스트(PLN-74809) 320mg 용량
벡소테그라스트(PLN-74809) 320mg 용량 - 52주
|
PLN-74809
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Forced Vital Capacity at Week 52
기간: Baseline (Day 1) and Week 52
|
The FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
|
Baseline (Day 1) and Week 52
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Forced Vital Capacity in Participants on and Not on Background Therapy at Week 52
기간: Baseline (Day 1) and Week 52
|
The FVC was the total amount of air exhaled from the lungs during the lung function test measured by spirometer.
Background therapy included nintedanib or pirfenidone.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
Change from baseline in FVC was assessed for participants on background therapy and not on background therapy at Baseline.
|
Baseline (Day 1) and Week 52
|
|
Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Dyspnea and Cough Domain Scores at Week 52
기간: Baseline (Day 1) and Week 52
|
The L-PF questionnaire was developed to assess symptoms and health-related quality of life in participants with IPF.
Questionnaire consisted of 44 items divided into 2 modules: symptoms (23 items) and impacts (21 items).
Dyspnea (shortness of breath) symptom domain consisted of 12 items, each item score ranged from 0 to 5 and cough symptom domain consisted of 6 items, each item score ranged from 0 to 4. Total score was calculated based on average of item ratings within each domain, multiplied by 100; ranged from 0 to 100 with higher scores indicated greater impairment of disease.
Baseline: data collected prior to and closest to administration of first dose of study drug (bexotegrast or placebo).
Change from Baseline in L-PF dyspnea and cough domain scores are presented here.
|
Baseline (Day 1) and Week 52
|
|
Number of Participants With an Event of Disease Progression
기간: Baseline (Day 1) and up to Week 52
|
Number of participants with an event of disease progression was defined as time to first occurrence of ≥10% absolute decline from baseline in forced vital capacity percent predicted (FVCpp), adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation, or all-cause mortality.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
The ITT population included all randomized participants, regardless of study drug exposure.
|
Baseline (Day 1) and up to Week 52
|
|
Change From Baseline in Quantitative Lung Fibrosis (QLF) Extent at Week 52
기간: Baseline (Day 1) and Week 52
|
High-resolution computerized tomography (HRCT) scans were conducted to assess the extent of QLF in the whole lung.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
The CT protocol population included all participants in the ITT analysis set with evaluable HRCT imaging data per the following criteria: Baseline HRCT scans were <35 days from randomization, Participant did not experience an exacerbation or progression of IPF AE within approximately 2 weeks prior to a HRCT scan, No identification of HRCT quality issues per the HRCT Imaging Charter.
|
Baseline (Day 1) and Week 52
|
|
Percentage of Participants With a ≥10% Absolute Decline in Forced Vital Capacity Percent Predicted From Baseline or All-cause Mortality Through Week 52
기간: Baseline (Day 1) and up to Week 52
|
Percentage of participants with a ≥10% absolute decline in FVCpp from baseline or all-cause mortality through Week 52 was planned.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
The ITT population included all randomized participants, regardless of study drug exposure.
|
Baseline (Day 1) and up to Week 52
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
기간: From first dose of study drug (Day 1) up to 14 days post last dose of study drug, up to 378 days
|
An AE was any event, side-effect, or other untoward medical occurrence that occurred in conjunction with the use of a study drug in humans, whether or not considered to have a causal relationship to the study drug.
An SAE was any untoward medical occurrence, that any dose, was life-threatening, resulted in death, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or an important medical event.
TEAEs were AEs that emerged or worsened in severity after the first administration of study drug and 14 days post last dose of study drug.
The safety population included all participants who were randomized into the study and received at least 1 dose of study drug.
|
From first dose of study drug (Day 1) up to 14 days post last dose of study drug, up to 378 days
|
|
Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score at Week 52
기간: Baseline (Day 1) and Week 52
|
The K-BILD was a brief, self-completed health status measure of ILD which contained 15 items that measured health status in 3 domains (breathlessness and activities [4 items], chest symptoms [3 items], and psychological [7 items]) on a 7-point Likert scale ranging from 0 (severe symptoms) to 6 (no symptoms at all).
The K-BILD domain and total score ranges were weighted and transformed; total score ranged from 0 to 100 with higher scores indicated best health status.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
|
Baseline (Day 1) and Week 52
|
|
Number of Participants With Disease Progression for Hazard Ratio
기간: Baseline (Day 1) and up to Week 52
|
Number of participants with disease progression (defined as adjudicated hospitalization, adjudicated acute IPF exacerbation, or all-cause mortality) for hazard ratio.
Baseline was defined as data collected prior to and closest to administration of the first dose of study drug (bexotegrast or placebo).
The ITT population included all randomized participants, regardless of study drug exposure.
|
Baseline (Day 1) and up to Week 52
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Pliant Therapeutics Medical Monitor, Pliant Therapeutics, Inc.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
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)
2023년 11월 16일
기본 완료 (실제)
2025년 4월 4일
연구 완료 (실제)
2025년 4월 4일
연구 등록 날짜
최초 제출
2023년 10월 18일
QC 기준을 충족하는 최초 제출
2023년 10월 18일
처음 게시됨 (실제)
2023년 10월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 3일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PLN-74809-IPF-206
- BEACON-IPF (기타 식별자: Pliant Therapeutics Inc)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
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. .