成都Bexotegrast片III期临床试验-一项评价 PLN-74809 (Bexotegrast）治疗特发性肺纤维化的有效性和安全性的随机、双盲、剂量范围探索、安慰剂对照研究 (BEACON-IPF)

登记号	CTR20243948	试验状态	进行中
申请人联系人	郭蓉	首次公示信息日期	2024-10-18
申请人名称	Pliant Therapeutics, Inc./ 艾昆纬医药科技（上海）有限公司/ Quotient Sciences - Philadelphia, LLC; Patheon Inc./ Anderson Brecon, Inc., dba PCI Pharma Services

登记号	CTR20243948
相关登记号	暂无
药物名称	Bexotegrast片
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	特发性肺纤维化
试验专业题目	一项评价 PLN-74809 (Bexotegrast）治疗特发性肺纤维化的有效性和安全性的随机、双盲、剂量范围探索、安慰剂对照研究(BEACON-IPF)
试验通俗题目	一项评价 PLN-74809 (Bexotegrast）治疗特发性肺纤维化的有效性和安全性的随机、双盲、剂量范围探索、安慰剂对照研究 (BEACON-IPF)
试验方案编号	PLN-74809-IPF-206	方案最新版本号	版本2.2
版本日期:	2024-04-30	方案是否为联合用药	否

申请人名称	[["Pliant Therapeutics, Inc."],["艾昆纬医药科技（上海）有限公司"],["Quotient Sciences - Philadelphia, LLC; Patheon Inc."],["Anderson Brecon, Inc., dba PCI Pharma Services"]]
联系人姓名	郭蓉	联系人座机	021-24228888	联系人手机号
联系人Email	jane.guo@iqvia.com	联系人邮政地址	上海市-上海市-浦东新区耀龙路1359号	联系人邮编	200124

主要目的：表征第52周时bexotegrast相比安慰剂对特发性肺纤维化（ IPF）受试者的用力肺活量（FVC）变化的影响。次要目的：1.表征52周治疗期间 bexotegrast相比安慰剂对疾病进展的影响。2.在基线接受和未接受背景治疗的IPF受试者中，表征第52周时bexotegrast相比安慰剂对FVC变化的影响。3.表征52周治疗后 bexotegrast相比安慰剂对IPF总体症状和功能改善的影响。4.利用高分辨率计算机断层扫描（HRCT），表征第52周时bexotegrast相比安慰剂对肺纤维化改变的影响。5.表征52周治疗期间 bexotegrast相比安慰剂在 IPF受试者中的安全性和耐受性。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国际多中心试验

年龄	40岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["筛选前年龄 ≥40岁"],["根据美国胸科学会 /欧洲呼吸学会 /日本呼吸学会 /拉丁美洲胸科学会2018指南，筛选前 ≤7年诊断为 IPF，并经研究中心审查证实 （Raghu et al 2018）。筛选前 ≤2年内进行的 HRCT扫描可用于资格评估"],["FVCpp ≥45%"],["DLCOpp（经血红蛋白校正 ）≥30%且 <90%"],["允许当前针对 IPF接受背景治疗，前提是筛选前剂量稳定 ≥12周"],["如果当前未接受 IPF治疗（初治或终止既往治疗），受试者在筛选前 8周内不得接受背景治疗"],["根据肌酐清除率的 Cockcroft-Gault公式，估计肾小球滤过率 ≥30 mL/min"],["无生育能力的女性受试者必须已手术绝育或处于绝经后状态（见方案第 5.7.4节）"],["女性伴侣有生育能力的男性受试者必须同意在筛选和治疗期间以及研究药物末次给药后至少 12周内采取年失败率 <1%的高效避孕措施，并使用避孕套（见方案第5.7.4节）"],["女性伴侣有生育能力的男性受试者必须同意在筛选和治疗期间以及研究药物末次给药后至少 12周内采取年失败率 <1%的高效避孕措施，并使用避孕套（见方案第5.7.4节）"],["同意在研究期间乃至研究药物末次给药后12周或4周避免捐献精子或卵子"],["了解研究程序，同意参加研究并提供书面知情同意"]]
排除标准	[["因肺动脉高压接受药物治疗"],["筛选时一秒用力呼气容积（FEV1）/FVC比值<0.7"],["存在活动性感染的临床证据，包括但不限于支气管炎、感染性肺炎或鼻窦炎，可能影响筛选或随机化时的FVC测量"],["存在人类免疫缺陷病毒、甲型肝炎、乙型肝炎或丙型肝炎活动性病毒感染"],["存在妨碍正确评估肺活量测定性能的任何其他状况（例如，肋骨 骨折或其他来源的胸痛，导致无法充分用力呼吸）"],["筛选前6个月内已知IPF急性加重或研究者怀疑IPF急性加重"],["与最近一次 HRCT扫描显示的纤维化改变程度相比肺气肿加重（采用中心阅片评估）；可使用筛选日期前 ≤2年内进行的HRCT扫描"],["受试者自我报告在筛选前 ≤12周内有任何类型的吸烟（不限于烟草），或不愿意在整个研究期间戒烟"],["筛选前4周内和/或筛选期间发生下呼吸道感染并需要抗生素治疗"],["在过去 5年内有恶性肿瘤病史或持续至今，不包括基底细胞癌、已切除的非浸润性皮肤鳞状细胞癌或接受过治疗的宫颈原位癌"],["记录显示存在肝功能损害，表现为肝功能不全（Child-Pugh分级为A、B或C）或终末期肝病"],["肾功能损害（定义为根据Cockcroft-Gault公式，估计肾小球滤过率<30 mL/min）或需要透析的终末期肾病"],["筛选前 6个月内曾出现不稳定 的 心脏或肺部疾病或疾病恶化（IPF除外），包括但不限于：a. 不稳定型心绞痛或心肌梗死。b. 筛选前 6个月内因充血性心力衰竭需要住院。c. 具有临床意义的未受控制的心律失常（例如，可能导致使用医疗资源或住院）"],["筛选时（包括第-1天）或研究药物首次给药前存在任何具有临床意义的 ECG异常，包括但不限于采用 Fridericia公式按心率校正的 QT间期(QTcF)>450 ms（男性）或 >460 ms（女性）"],["以下任何一项肝脏生化功能检查值超出规定范围：天门冬氨酸氨基转移酶AST）或丙氨酸氨基转移酶 ALT））>5.0×正常值上限（ULN）；总胆红素>3.0×ULN"],["筛选时存在下列任何一种情况：血红蛋白 <10.0 g/dL、中性粒细胞 <1500/mm3或血小板 <100,000/mL"],["妊娠或哺乳期女性受试者"],["每日使用磷酸二酯酶 5抑制剂药物（例如，西地那非、他达拉非等）注：允许间歇使用磷酸二酯酶5抑制剂治疗勃起功能障碍"],["已知影响研究药物吸收的药物治疗或手术（例如，胃大手术）"],["计划在研究期间接受手术"],["未受控制的体循环动脉高压（II级高血压，诊室血压 ≥160/100 mmHg [NICE guideline 2023]）"],["目前正在接受并预期在研究期间继续接受以下药物治疗：细胞色素 P450 (CYP) 3A4和 P-糖蛋白（例如伊曲康唑、利托那韦）、乳腺癌耐药蛋白或有机阴离子转运多肽1B1/1B3转运蛋白的强效抑制剂或诱导剂"],["对bexotegrast或任何辅料或安慰剂过敏"],["使用任何未经批准或试验用药物治疗IPF纤维化"],["在筛选前5个半衰期或30天内（以时间较长者为准）使用过试验用药物，或在筛选前30天内使用过试验用器械"],["既往接受过bexotegrast给药"],["可能在研究期间接受肺移植（不排除移植等待名单中的患者）"],["研究者认为可使潜在受试者不适合参加研究的任何医学状况。a. 若潜在受试者的药物筛查结果呈阳性，主要研究者必须评估受试者是否有潜在物质和/或酒精使用障碍，进而可能影响研究参与、研究药物依从性、研究访视和评估。评估结果必须记录在eCRF中，作为受试者满足资格要求的依据"],["接受尼达尼布和吡非尼酮联合治疗"],["参加任何其他试验用药物的干预性研究"]]

试验药	[["中文通用名:Bexotegrast片 英文通用名:BexotegrastTablets 商品名称:NA","剂型:片剂 规格:160mg 用法用量:口服给药。研究药物每日给药一次，大约间隔24小时。 用药时程:52周"]] 序号 名称 用法
对照药	[["中文通用名:匹配安慰剂片 英文通用名:MatchingPlacebo 商品名称:NA","剂型:片剂 规格:NA 用法用量:口服给药。研究药物每日给药一次，大约间隔24小时。 用药时程:52周"]] 序号 名称 用法

主要终点指标及评价时间

[["第52周时FVC绝对值（mL）较基线的变化","52周","有效性指标"]] 序号 指标 评价时间 终点指标选择

次要终点指标及评价时间

[["至疾病进展时间，定义为截至第52周首次发生用力肺活量占预计值百分比（FVCpp）较基线的绝对降幅≥10%、裁定的呼吸系统疾病相关住院、裁定的IPF急性加重或全因死亡的时间","52周","有效性指标"],["至疾病进展时间，定义为截至第52周首次发生裁定的呼吸系统疾病相关住院、裁定的IPF急性加重或全因死亡的时间","52周","有效性指标"],["截至第52周FVCpp较基线的绝对降幅≥10%或全因死亡的受试者比例","52周","有效性指标"],["52周时FVC绝对值（mL）较基线的变化n●t基线接受背景治疗的受试者","52周","有效性指标"],["52周时FVC绝对值（mL）较基线的变化n●t基线未接受背景治疗的受试者","52周","有效性指标"],["第52周时L-PF呼吸困难维度评分较基线的变化","52周","有效性指标"],["第52周时L-PF咳嗽维度评分较基线的变化","52周","有效性指标"],["第52周时King间质性肺疾病简短量表（K-BILD）总评分较基线的变化","52周","有效性指标"],["第52周时定量肺纤维化（QLF）程度（%）较基线的绝对变化","52周","有效性指标"],["发生治疗中出现的不良事件和严重不良事件的受试者比例","52周","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	罗凤鸣	学位	医学博士	职称	主任医师，院长
	电话	18980601355	Email	fengmingluo@outlook.com	邮政地址	四川省-成都市-武侯区国学巷37号
	邮编	610041	单位名称	四川大学华西医院

[["四川大学华西医院","罗凤鸣","中国","四川省","成都市"],["北京协和医院","徐作军","中国","北京市","北京市"],["徐州医科大学附属医院","陈碧","中国","江苏省","常州市"],["南方医科大学南方医院","孟莹","中国","广东省","广州市"],["安徽医科大学第二附属医院","赵卉","中国","安徽省","合肥市"],["中南大学湘雅二医院","彭红","中国","湖南省","长沙市"],["南昌大学第一附属医院","张伟","中国","江西省","南昌市"],["四川省人民医院","高凌云","中国","四川省","成都市"],["内蒙古医科大学附属医院","高俊珍","中国","内蒙古自治区","呼和浩特市"],["杭州市第一人民医院","王利民","中国","浙江省","杭州市"],["河南省人民医院","张晓菊","中国","河南省","郑州市"],["无锡市人民医院","卞涛","中国","江苏省","无锡市"],["南京鼓楼医院","曹敏","中国","江苏省","南京市"],["浙江大学医学院附属邵逸夫医院","陈恩国","中国","浙江省","杭州市"],["复旦大学附属中山医院","洪群英","中国","上海市","上海市"],["武汉大学人民医院","聂汉祥","中国","湖北省","武汉市"],["宜昌市中心人民医院","李晓娟","中国","湖北省","宜昌市"],["山东大学齐鲁医院","马德东","中国","山东省","济南市"],["河南省胸科医院","郭彩霞","中国","河南省","郑州市"],["中国医科大学附属盛京医院","郑锐","中国","辽宁省","沈阳市"],["郑州大学第一附属医院","张国俊","中国","河南省","郑州市"],["吉林大学第二医院","张捷","中国","吉林省","长春市"],["广州医科大学附属第一医院","罗群","中国","广东省","广州市"],["河北医科大学第三医院","赵云霞","中国","河北省","石家庄市"],["天津医科大学总医院","曹洁","中国","天津市","天津市"],["Centro de Investigaciones Medicas Mar del Plata","Jorge Taborda","阿根廷","Buenos Aires","Mar del Plata"],["Hospital Britanico de Buenos Aires","Alejandro Salvado","阿根廷","Ciudad Autonoma Buenos Aires","Ciudad Autonoma Buenos Aires"],["CEMER - Centro Medico de Enfermedades Respiratorias","Miguel Angel Bergna","阿根廷","Buenos Aires","Vicente Lopez"],["Centro Respiratorio Quilmes","Marcelo Jose Fernandez","阿根廷","Buenos Aires","Quilmes"],["Fundacion Scherbovsky","Pablo Saez Scherbovsky","阿根廷","Mendoza","Mendoza"],["Instituto de Medicina Respiratoria - IMeR","Alexis Cazaux","阿根廷","Cordoba","Cordoba"],["Centro Medico Dra. De Salvo","Maria Cristina De Salvo","阿根廷","Buenos Aires","Capital Federal"],["CIMER - Centro Integral de Medicina Respiratoria","Hector Altieri","阿根廷","Tucuman","San Miguel de Tucumán"],["Consultorios Medicos del Buen Ayre","Gaston De Stefano","阿根廷","Ciudad Autonoma Buenos Aires","Ciudad Autonoma Buenos Aires"],["Sanatorio Parque S.A.","Silvina Mannarino","阿根廷","Santa Fe","Rosario"],["Instituto Ave Pulmo","Luis Wehbe","阿根廷","Buenos Aires","Mar del Plata"],["INSARES S.A.","Pedro Carlos Elias","阿根廷","Mendoza","Mendoza"],["Clinica Independencia","Oscar Salva","阿根廷","Buenos Aires","Munro"],["Instituto Medico de la Fundacion Estudios Clinicos","Nadia Brandan","阿根廷","Santa Fe","Rosario"],["Centro de Investigacion Clinica – CEDIC","Alberto Casey","阿根廷","Ciudad Autonoma Buenos Aires","Buenos Aires"],["Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica","Federico Massola","阿根廷","Santa Fe","Rosario"],["Flinders Medical Centre","Huw Davies","澳大利亚","South Australia","Bedford Park"],["Lung Research QLD Pty Ltd","Daniel Chambers","澳大利亚","Queensland","Chermside"],["Respiratory Clinical Trials","Michael Chia","澳大利亚","South Australia","Toorak Gardens"],["Monash Medical Centre","Xun Li","澳大利亚","Victoria","Clayton"],["Royal Prince Alfred Hospital","Tamera Corte","澳大利亚","New South Wales","Camperdown"],["Fiona Stanley Hospital","Meow Yaw","澳大利亚","Western Australia","Murdoch"],["The Alfred","Ian Glaspole","澳大利亚","Victoria","Melbourne"],["Austin Health","Nicole Goh","澳大利亚","Victoria","Heidelberg"],["Institute for Respiratory Health Inc","David Manners","澳大利亚","Western Australia","Nedlands"],["Box Hill Hospital","Francis Thien","澳大利亚","Victoria","Box Hill"],["TrialsWest","Peter Bremner","澳大利亚","Western Australia","Spearwood"],["The Queen Elizabeth Hospital","Thomas Altree","澳大利亚","South Australia","Woodville South"],["UZ Leuven","Wim Wuyts","比利时","Leuven","Leuven"],["AZ Delta VZW","Ulrike Himpe","比利时","Roeselare","Roeselare"],["CENTRE HOSPITALIER UNIVERSITAIRE DE LIEGE","Julien Guiot","比利时","Liege","Liege"],["Hospital Nossa Senhora da Conceicao","Waldo Luis Leite Dias de Mattos","巴西","Rio Grande do Sulv","Porto Alegre"],["Hospital S？o Lucas da PUCRS","Daniela Cavalet Blanco","巴西","Rio Grande do Sul","Porto Alegre"],["Irmandade da Santa Casa de Misericórdia de Porto Alegre","Adalberto Sperb Rubin","巴西","Rio Grande do Sul","Porto Alegre"],["Irmandade da Santa Casa da Misericordia de Santos","Alex Macedo","巴西","Sao Paulo","Santos"],["Hospital de Clínicas de Porto Alegre","Marcelo Gazzana","巴西","Rio Grande do Sul","Porto Alegre"],["Hospital Ernesto Dornelles","Juliana Cardozo Fernandes","巴西","Rio Grande do Sul","Porto Alegre"],["Instituto Mederi de Pesquisa e Saude","Vinicius Buaes Dal Maso","巴西","Rio Grande do Sul","Passo Fundo"],["Santa Casa de Misericordia de Belo Horizonte","Deborah Estrella","巴西","Minas Gerais","Belo Horizonte"],["Hospital Cardio Pulmonar","Marcel Albuquerque","巴西","Bahia","Salvador"],["Universidade Federal do Estado de S？o Paulo (UNIFESP)","Carlos Alberto de Castro Pereira","巴西","Sao Paulo","Sao Paulo"],["Inspiration Research Limited","Kenneth Chapman","加拿大","Ontario","Toronto"],["St. Joseph's Healthcare Hamilton","Martin Kolb","加拿大","Ontario","Hamilton"],["CIC Mauricie Inc.","Emilie Millaire","加拿大","Quebec","Trois-Rivieres"],["Dynamic Drug Advancement","George Philteos","加拿大","Ontario","Ajax"],["St. Paul's Hospital","Christopher Ryerson","加拿大","British Columbia","Vancouver"],["CHUM","Julie Morisset","加拿大","Quebec","Montreal"],["Kelowna Respirology and Allergy Research","Jeffrey Rolf","加拿大","British Columbia","Kelowna"],["CISSS de la Monteregie-Centre","Nadim Srour","加拿大","Quebec","Greenfield Park"],["CIMER - Centro de Investigaciones Medicas Respiratorias","Patricia Fernandez","智利","Santiago","Santiago"],["Centro de Investigacion del Maule","Rafael Silva Orellana","智利","Talca","Talca"],["CENRESIN","Juana Rosa Pavie","智利","Quillota","Quillota"],["CTR Estudios","Victor Hugo Aliste Cerda","智利","Santiago","Santiago"],["CeCim Biocinetic","Carla Constanza Saavedra Pacheco","智利","Santiago","Santiago"],["CEC SPA","Georgina Miranda","智利","Santiago","Santiago"],["Fakultni nemocnice Brno","Martina Doubkova","捷克共和国","Brno","Brno"],["Fakultni Thomayerova nemocnice","Martina Sterclova","捷克共和国","Praha 4","Praha 4"],["Fakultni nemocnice Olomouc","Monika Zurkova","捷克共和国","Olomouc","Olomouc"],["Arhus Universitetshospital","Elisabeth Bendstrup","丹麦","Arhus N","Arhus N"],["Herlev og Gentofte Hospital","Saher Shaker","丹麦","Hellerup","Hellerup"],["Odense Universitetshospital","Ingrid Titlestad","丹麦","Odense","Odense"],["Hopital Bichat - Claude Bernard","Bruno Crestani","法国","Paris","Paris"],["CHU Tours - Hopital Bretonneau","Sylvain Marchand Adam","法国","Indre et Loire","Tours cedex"],["Hopital Arnaud de Villeneuve","Arnaud Bourdin","法国","Herault","Montpellier cedex 5"],["Hopital Larrey","Grégoire Prévot","法国","Haute Garonne","Toulouse"],["CHU Lyon - Hopital Cardio-Vasculaire et Pneumologique Louis Pradel","Vincent Cottin","法国","Rhone","Bron"],["CHU Reims - Hopital Maison Blanche","Francois Lebargy","法国","Marne","Reims"],["Hopital Nord - CHU Marseille","Martine Reynaud-Gaubert","法国","Bouches-du-Rh？ne","Marseille"],["CHU de Bordeaux- Hopital du Haut Lévêque","Elodie Blanchard","法国","Gironde","Pessac"],["CHU Rennes - Hopital Pontchaillou","Stéphane Jouneau","法国","Ille et Vilaine","Rennes cedex 09"],["Institut Coeur Poumon - CHU de Lille","Lidwine Wemeau","法国","Nord","Lille"],["CHU Nice - Hopital Pasteur","Sylvie Leroy","法国","Alpes Maritimes","Nice cedex 1"],["Hopital Avicenne","Hilario Nunes","法国","Seine St Denis","Bobigny cedex"],["Asklepios Fachkliniken München-Gauting","Wolfgang Gesierich","德国","Bayern","Gauting"],["Fachkrankenhaus Coswig GmbH","Dirk Koschel","德国","Sachsen","Coswig"],["Medizinische Hochschule Hannover","Jonas Schupp","德国","Niedersachsen","Hannover"],["Universitaetsklinikum des Saarlandes","Heinrike Wilkens","德国","Saarland","Homburg"],["Universitaetsklinikum Leipzig AoeR","Hubert Wirtz","德国","Sachsen","Leipzig"],["Evangelische Lungenklinik Berlin","Christian Grohe","德国","Berlin","Berlin"],["Krankenhaus Bethanien","Lars Hagmeyer","德国","Nordrhein Westfalen","Solingen"],["Universitaetsmedizin Greifswald","Beate Stubbe","德国","Mecklenburg Vorpommern","Greifswald"],["Ruhrlandklinik","Francesco Bonella","德国","Nordrhein Westfalen","Essen"],["Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen","Andreas Guenther","德国","Hessen","Giessen"],["IKF Pneumologie GmbH & Co. KG","Marc Oliver Kornmann","德国","Hessen","Frankfurt am Main"],["Klinikum der Universitaet Muenchen","Juergen Behr","德国","Bayern","Muenchen"],["University Hospital of Schleswig-Holstein","Jan Heyckendorf","德国","Schleswig Holstein","Kiel"],["ARDS and ECMO Zentrum Koln Merheim Lungcentre Cologne Merheim","Christian Karagiannidis","德国","Nordrhein Westfalen","Koeln"],["Zentralklinik Bad Berka GmbH","Michael Weber","德国","Thueringen","Bad Berka"],["University General Hospital of Alexandroupolis","Paschalis Steiropoulos","希腊","Alexandroupolis","Alexandroupolis"],["University General Hospital of Larissa","Zoe Daniil","希腊","Larisa","Larisa"],["University General Hospital of Heraklion","Katerina Antoniou","希腊","Heraklion","Heraklion"],["University General Hospital of Ioannina","Konstantinos Kostikas","希腊","Ioannina","Ioannina"],["General Hospital of Thessaloniki","Despina Papakosta","希腊","Thessaloniki","Thessaloniki"],["University General Hospital of Patras","Argyris Tzouvelekis","希腊","Patra","Patra"],["General Hospital of Athens of Chest Diseases","Lykourgos Kolilekas","希腊","Athens","Athens"],["K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre","Jyothi Hattiholi","印度","Karnataka","Belagavi"],["Unity Hospital ICU and Trauma","Dipak Viradia","印度","Gujarat","Surat"],["Asthma Bhavan","Ashish Kumar","印度","Rajasthan","Jaipur"],["Rhythm Heart Institute","Tejas Kakkad","印度","Gujarat","Vadodara"],["Calcutta Medical Research Institute","Raja Dhar","印度","West Bengal","Kolkata"],["B. P. Poddar Hospital and Medical Research Limited","Samadarshi Datta","印度","West Bengal","Kolkata"],["J.L.N., Medical College and Attached Hospitals","Piyush Arora","印度","Rajasthan","Ajmer"],["Max Institute of Neurosciences","Vivek Nangia","印度","Delhi","New Delhi"],["Bhatia Hospital","Sujeet Rajan","印度","Maharashtra","Mumbai"],["Siddhi Hospital","Abhinandan Mutha","印度","Maharashtra","Nashik"],["ESIC Medical College and Hospital","Manas Kamal Sen","印度","Haryana","Faridabad"],["Midland Healthcare & Research Center","Bhanu Singh","印度","Uttar Pradesh","Lucknow"],["BHS Lakeview Hospital","Gururaj Udchankar","印度","Karnataka","Belagavi"],["SDS TRC & Rajiv Gandhi Institute of Chest Disease","Akshata Shivananjaiah","印度","Karnataka","Bangalore"],["Soroka University Medical Center","Yael Raviv","以色列","Beer-Sheva","Beer-Sheva"],["Meir Medical Center","David Shitrit","以色列","Kfar Saba","Kfar Saba"],["Kaplan Medical Center","Gershon Fink","以色列","Rehovot","Rehovot"],["Chaim Sheba Medical Center","Michael Segel","以色列","Ramat Gan","Ramat Gan"],["Rambam Medical Center","Yaniv Dotan","以色列","Haifa","Haifa"],["Rabin Medical Center-Beilinson Campus","Mordechai Kramer","以色列","Petah Tikva","Petah Tikva"],["Barzilai Medical Center","Ori Wand","以色列","Ashkelon","Ashkelon"],["Shaare Zedek","Gabriel Izbicki","以色列","Jerusalem","Jerusalem"],["The Lady Davis Carmel Medical Center","Yochai Adir","以色列","Haifa","Haifa"],["Tel Aviv Sourasky Medical Center","Amir Bar-Shai","以色列","Tel Aviv","Tel Aviv"],["Fondazione IRCCS San Gerardo dei Tintori","Fabrizio Luppi","意大利","Monza","Monza"],["Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)","Patrizio Vitulo","意大利","Palermo","Palermo"],["Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)","Fabiano Di Marco","意大利","Bergamo","Bergamo"],["Ospedale San Giuseppe Multimedica SpA","Sergio Harari","意大利","Milan","Milan"],["Azienda Ospedaliera Universitaria Careggi","Sara Tomassetti","意大利","Firenze","Firenze"],["Azienda Ospedaliero - Universitaria Nazionale Santi Antonio e Biagio e Cesare Arrigo","Mario Salio","意大利","Alessandria","Alessandria"],["Azienda Ospedaliera Universitaria Senese","Elena Bargagli","意大利","Siena","Siena"],["A.O.U. Policlinico di Modena","Stefania Cerri","意大利","Modena","Modena"],["Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Luca Richeldi","意大利","Roma","Roma"],["Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia","Donato Lacedonia","意大利","Foggia","Foggia"],["Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino","Rocco Francesco Rinaldo","意大利","Torino","Torino"],["Nippon Medical School Hospital","Koichiro Kamio","日本","Tokyo-To","Bunkyo-ku"],["Aso Co.,Ltd Iizuka Hospital","Kazunori Tobino","日本","Fukuoka-Ken","Iizuka-shi"],["Okayama University Hospital","Hisao Higo","日本","Okayama-Ken","Okayama-shi"],["Hospital of the University of Occupational and Environmental Health","Kazuhiro Yatera","日本","Fukuoka-Ken","Kitakyushu-shi"],["Saitama Prefectural Cardiovascular and Respiratory Center","Naho Kagiyama","日本","Saitama-Ken","Kumagaya-shi"],["Shimane University Hospital","Megumi Hamaguchi","日本","Shimane-Ken","Izumo-shi"],["NHO Ibarakihigashi National Hospital","Takefumi Saito","日本","Ibaraki-Ken","Naka-gun"],["Kanagawa Cardiovascular and Respiratory Center","Takashi Ogura","日本","Kanagawa-Ken","Yokohama-shi"],["Tokyo Medical and Dental University Hospital","Yasunari Miyazaki","日本","Tokyo-To","Bunkyo-ku"],["Kobe City Hospital Organization Kobe City Medical Center General Hospital","Ryo Tachikawa","日本","Hyogo-Ken","Kobe-shi"],["Saitama Red Cross Hospital","Hidekazu Matsushima","日本","Saitama-Ken","Saitama-shi"],["Hamamatsu University School of Medicine, University Hospital","Takafumi Suda","日本","Shizuoka-Ken","Hamamatsu-shi"],["NHO Kyushu Medical Center","Masaki Okamoto","日本","Fukuoka-Ken","Fukuoka-shi"],["Juntendo University Hospital","Motoyasu Kato","日本","Tokyo-To","Bunkyo-ku"],["Kobe City Hospital Organization Kobe City Medical Center West Hospital","Hiromi Tomioka","日本","Hyogo-Ken","Kobe-shi"],["Sapporo Medical University Hospital","Hirofumi Chiba","日本","Hokkaido","Sapporo-shi"],["NHO Kinki-Chuo Chest Medical Center","Toru Arai","日本","Osaka-Fu","Sakai-shi"],["Hiroshima Prefectural Hospital","Nobuhisa Ishikawa","日本","Hiroshima-Ken","Hiroshima-shi"],["Tokushima University Hospital","Seidai Sato","日本","Tokushima-Ken","Tokushima-shi"],["Kumamoto University Hospital","Hidenori Ichiyasu","日本","Kumamoto-Ken","Kumamoto-shi"],["Fukuoka University Hospital","Masaki Fujita","日本","Fukuoka-Ken","Fukuoka-shi"],["Toho University Omori Medical Center","Kazuma Kishi","日本","Tokyo-To","Ota-ku"],["Fukushima Medical University Hospital","Yoshinori Tanino","日本","Fukushima-Ken","Fukushima-shi"],["NHO Okinawa National Hospital","Isoko Owan","日本","Okinawa-Ken","Ginowan-shi"],["SeveranceHospital, Yonsei University Health System","Song Yee Kim","韩国","Seoul","Seoul"],["The Catholic University of Korea, Seoul St. Mary’s Hospital","Yong Suk Jo","韩国","Seoul","Seoul"],["Korea University Anam Hospital","Eun Joo Lee","韩国","Seoul","Seoul"],["Asan Medical Center","Jin Woo Song","韩国","Seoul","Seoul"],["Inje University Busan Paik Hospital","Hyun-Kyung Lee","韩国","Busan","Busan"],["Inje University Haeundae Paik Hospital","Jae Ha Lee","韩国","Busan","Busan"],["Hanyang University Seoul Hospital","Hyun Lee","韩国","Seoul","Seoul"],["Zuyderland Medisch Centrum - Heerlen","Remy Mostard","荷兰","Heerlen","Heerlen"],["St. Antonius Ziekenhuis","Marcel Veltkamp","荷兰","Nieuwegein","Nieuwegein"],["Amsterdam UMC, Locatie VUMC","Bart Boerrigter","荷兰","Amsterdam","Amsterdam"],["Waikato Hospital","Catherina Chang","新西兰","Hamilton","Hamilton"],["Christchurch Hospital NZ","Michael Epton","新西兰","Christchurch","Christchurch"],["Dunedin Hospital","Benedict Brockway","新西兰","Dunedin","Dunedin"],["Greenlane Clinical Centre","Sally De Boer","新西兰","Epsom","Epsom"],["MICS Centrum Medyczne Bydgoszcz","Agnieszka Jarzemska","波兰","Bydgoszcz","Bydgoszcz"],["Zanamed Medical Clinic sp z o o","Barbara Mackiewicz","波兰","Lublin","Lublin"],["Vitamed Galaj i Cichomski sp.j.","Iwona Patyk","波兰","Bydgoszcz","Bydgoszcz"],["SP ZOZ Szpital Uniwersytecki w Krakowie","Krzysztof Sladek","波兰","Kraków","Kraków"],["IP Clinic","Sebastian Majewski","波兰","Lodz","Lodz"],["Twoja Przychodnia NCM","Anna Polanska-Eisler","波兰","Nowa Sol","Nowa Sol"],["Pulmag Grzegorz Gasior Marzena Kociolek","Grzegorz Gasior","波兰","Sosnowiec","Sosnowiec"],["Uniwersyteckie Centrum Kliniczne","Alicja Sieminska","波兰","Gdansk","Gdansk"],["Unidade Local de Saúde de Matosinhos, EPE","Ines Neves","葡萄牙","Matosinhos","Matosinhos"],["Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.","Sergio Andre Campainha Fernandes","葡萄牙","Vila Nova de Gaia","Vila Nova de Gaia"],["Centro Clinico Academico Braga Associacao 2CA Braga","Rui Rolo","葡萄牙","Braga","Braga"],["Hospital de Santa Marta","Alexandra Borba","葡萄牙","Lisboa","Lisboa"],["Mersin University Medical Faculty","Sibel Atis Nayci","土耳其","Mersin","Mersin"],["Istanbul University Istanbul Medical Faculty, Drug Researh Center","Nigar Gulfer Okumus","土耳其","Istanbul","Istanbul"],["Uludag University Medical Faculty","Funda Coskun","土耳其","Bursa","Bursa"],["Yedikule Pulmonary Dis. and Surgery Edu. and Res. Hosp.","Erdogan Cetinkaya","土耳其","Istanbul","Istanbul"],["Erciyes University Medical Faculty","Nuri Tutar","土耳其","Kayseri","Kayseri"],["Cukurova University Medical Faculty","Ismail Hanta","土耳其","Adana","Adana"],["Ege University Medical Faculty","Nesrin Mogulkoc","土耳其","Izmir","Izmir"],["Gazi University Medical Faculty","Nilgun Yilmaz Demirci","土耳其","Ankara","Ankara"],["Gulhane Training and Research Hospital","Nesrin Ocal","土耳其","Ankara","Ankara"],["National Taiwan University Hospital","Hao-Chien Wang","中国台湾","Taipei","Taipei"],["Taipei Veterans General Hospital","Wei-Chih Chen","中国台湾","Taipei","Taipei"],["Taichung Veterans General Hospital","Ming-Cheng Chan","中国台湾","Taichung","Taichung"],["Far Eastern Memorial Hospital","Shih-Lung Cheng","中国台湾","New Taipei City","New Taipei City"],["Kaohsiung Medical University Chung-Ho Memorial Hospital","Chau-Chyun Sheu","中国台湾","Kaohsiung","Kaohsiung"],["China Medical University Hospital","Chia-Hung Chen","中国台湾","Taichung","Taichung"],["Clinica Universidad de Navarra","Arantza Campo Ezquibela","西班牙","Navarra","Pamplona"],["Giromed Institute Barcelona - Pectus Respiratory Health","Juan Roldan Sanchez","西班牙","Barcelona","Barcelona"],["Hospital Universitari de Bellvitge","Maria Molina Molina","西班牙","Barcelona","L'Hospitalet de Llobregat"],["Hospital Clinico Universitario Virgen de la Victoria","Jose Luis Velasco Garrido","西班牙","Malaga","Malaga"],["Complejo Hospitalario Universitario de Vigo","Virginia Leiro Fernandez","西班牙","Pontevedra","Vigo"],["Hospital Clinic de Barcelona","Jacobo Sellares Torres","西班牙","Barcelona","Barcelona"],["Hospital Universitario Clinico San Carlos","Maria Asuncion Nieto Barbero","西班牙","Madrid","Madrid"],["Hospital Universitario Puerta de Hierro Majadahonda","Christian Garcia Fadul","西班牙","Madrid","Majadahonda"],["Hospital Universitario de La Princesa","Claudia Valenzuela","西班牙","Madrid","Madrid"],["Complejo Hospitalario Universitario de Santiago","Juan Suarez Antelo","西班牙","La Coruna","Santiago de Compostela"],["Glenfield Hospital","Fasihul Khan","英国","Leicestershire","Leicester"],["Royal Brompton Hospital","Philip Molyneaux","英国","Greater London","London"],["Western General Hospital","Gareth Stewart","英国","Lothian Region","Edinburgh"],["Castle Hill Hospital","Simon Hart","英国","East Riding of Yorkshire","Hull"],["Altnagelvin Area Hospital","Nazia Chaudhuri","英国","Derry","Londonderry"],["Southampton General Hospital","Sophie Fletcher","英国","Hampshire","Southampton"],["Birmingham Heartlands Hospital","Gareth Walters","英国","West Midlands","Birmingham"],["Pinderfields Hospital","Muthuramalingam Thirumaran","英国","West Yorkshire","Wakefield"],["Royal Papworth Hospital","Christine Fiddler","英国","Cambridgeshire","Cambridge"],["Peterborough City Hospital","Tiyassen Dutta","英国","Cambridgeshire","Peterborough"],["Churchill Hospital","Peter Saunders","英国","Oxfordshire","Oxford"],["Dignity Health d/b/a St. Joseph's Hospital and Medical Center","Rajat Walia","美国","Arizona","Phoenix"],["NewportNativeMD,Inc","Ryan Klein","美国","California","Newport Beach"],["Florida Lung, Asthma and Sleep Specialists","Fortune Alabi","美国","Florida","Celebration"],["Velocity Clinical Research, Greenville","Luis De la Cruz","美国","South Carolina","Greenville"],["The University of Chicago Medical Center","Ayodeji Adegunsoye","美国","Illinois","Chicago"],["Univ. of Kentucky - Lexington","Ketan Buch","美国","Kentucky","Lexington"],["Dartmouth-Hitchcock Medical Center","Richard Enelow","美国","New Hampshire","Lebanon"],["University of California San Francisco","Jeffrey Golden","美国","California","San Francisco"],["Danbury Hospital","Douglas Kahn","美国","Connecticut","Danbury"],["University of Oklahoma Health Sciences Center","Jad Kebbe","美国","Oklahoma","Oklahoma City"],["University of Tennessee Medical Center","Jared Kravitz","美国","Tennessee","Knoxville"],["University of Pennsylvania School of Medicine","Mary Kreider","美国","Pennsylvania","Philadelphia"],["Vanderbilt University Medical Center","Lisa Lancaster","美国","Tennessee","Nashville"],["UC Davis Medical Center","Timothy Albertson","美国","California","Sacramento"],["DuBois Regional Medical Center","Sandeep Bansal","美国","Pennsylvania","DuBois"],["Penn State Hershey Pulmonary Medicine","Rebecca Bascom","美国","Pennsylvania","Hershey"],["Indiana University","Ryan Boente","美国","Indiana","Indianapolis"],["Clinical Site Partners, LLC Leesburg dba Flourish Research","Jose Diaz","美国","Florida","Leesburg"],["Bend Memorial Clinic","Jeremy Feldman","美国","Oregon","Bend"],["Meris Clinical Research, LLC","Alexandre Furman","美国","Florida","Brandon"],["University of Kansas Medical Center Research Institute, Inc.","Mark Hamblin","美国","Kansas","Kansas City"],["University of Minnesota Medical Center","Hyun Kim","美国","Minnesota","Minneapolis"],["VA Medical C*","Ware Kuschner","美国","California","Palo Alto"],["Metroplex Pulmonary and Sleep Center","Shakil Ahmed","美国","Texas","McKinney"],["University of Michigan","Elizabeth Belloli","美国","Michigan","Ann Arbor"],["Banner University Medical Center","Sachin Chaudhary","美国","Arizona","Tucson"],["Loyola University Health System","Daniel Dilling","美国","Illinois","Maywood"],["El Paso Pulmonary Association","Carlo Hatem","美国","Texas","EL PASO"],["Lowcountry Lung and Critical Care, P.A.","Thomas Kaelin","美国","South Carolina","Charleston"],["INOVA Fairfax Medical Campus","Christopher King","美国","Virginia","Falls Church"],["Metroplex Pulmonary and Sleep Center","Shahrukh Kureishy","美国","Texas","McKinney"],["Stanford Hospital and Clinics","Joshua Mooney","美国","California","Palo Alto"],["Creighton University","Lee Morrow","美国","Nebraska","Omaha"],["Allergy & Asthma Specialists, PSC","Danielle Antin-Ozerkis","美国","Connecticut","New Haven"],["University of Maryland Medical Center","Edward Britt","美国","Maryland","Baltimore"],["The Lung Research Center, LLC","Neil Ettinger","美国","Missouri","Chesterfield"],["National Jewish Center","Evans Fernandez Perez","美国","Colorado","Denver"],["Brigham and Women's Hospital - PARENT","Gary Hunninghake","美国","Massachusetts","Boston"],["University of Alabama at Birmingham - (UAB)","Tejaswini Kulkarni","美国","Alabama","Birmingham"],["Mayo Clinic","Andrew Limper","美国","Minnesota","Rochester"],["Clinical Trials Center of Middle Tennessee","Aaron Milstone","美国","Tennessee","Franklin"],["Icahn School of Medicine at Mount Sinai","Maria Padilla","美国","New York","New York"],["Georgetown University Hospital-Medstar","Cristina Reichner","美国","District of Columbia","Washington"],["Tulane University Heart & Vascular Institute","Joseph Lasky","美国","Louisiana","New Orleans"],["Infinity Medical Research Inc","Curtis Mello","美国","Massachusetts","North Dartmouth"],["Massachusetts General Hospital","Sydney Montesi","美国","Massachusetts","Boston"],["Arizona Pulmonary Specialists, Ltd","Akshay Muralidhar","美国","Arizona","Scottsdale"],["Baylor College of Medicine","Ivan Rosas","美国","Texas","Houston"],["Henry Ford Columbus Center","Krishna Thavarajah","美国","Michigan","Detroit"],["Critical Care, Pulmonary and Sleep Associates","Dominic Titone","美国","Colorado","Lakewood"],["Western Washington Medical Group","Tomasz Ziedalski","美国","Washington","Everett"],["University of Colorado Hospital","Joyce Lee","美国","Colorado","Aurora"],["Paradigm Clinical Research Centers, LLC","Rafael Lupercio","美国","California","Redding"],["Montefiore Medical Center Moses Division Hospital","Ali Mansour","美国","New York","Bronx"],["Duke University Health System","Lake Morrison","美国","North Carolina","Durham"],["Lebauer Health Center","Murali Ramaswamy","美国","North Carolina","Greensboro"],["University of Utah Hospitals & Clinics","Mary Beth Scholand","美国","Utah","Salt Lake City"],["Renovatio Clinical","Ather Siddiqi","美国","Texas","The Woodlands"],["StatCare Pulmonary Consultants","Eric Weaver","美国","Tennessee","Knoxville"],["Jeffrey S. Sager, MD Medical Corporation","Jeffrey Sager","美国","California","Santa Barbara"],["Palmtree Clinical Research, Inc.","Ziad Tannous","美国","California","Palm Springs"],["Salem Chest Specialists","Jason Thomason","美国","North Carolina","Winston Salem"],["Cleveland Clinic Florida - Weston","David Zisman","美国","Florida","Weston"],["University of Texas - Southwestern Medical Center","John Fitzgerald","美国","Texas","DALLAS"],["Baylor Scott & White Research Institute Dallas","Yolanda Mageto","美国","Texas","Dallas"],["Norton Pulmonary Specialists","John McConnell","美国","Kentucky","Louisville"],["Augusta University","Varsha Taskar","美国","Georgia","Augusta"],["The Emory Clinic","Srihari Veeraraghavan","美国","Georgia","Atlanta"],["Medical University of South Carolina","Timothy Whelan","美国","South Carolina","Charleston"],["Mayo Clinic - Jacksonville","Augustine Lee","美国","Florida","Jacksonville"],["University of Vermont Medical Center","Ena Gupta","美国","Vermont","Burlington"],["University of Cincinnati","Abhishek Singla","美国","Ohio","Cincinnati"],["University of Pittsburgh Medical Center","Eleanor Valenzi","美国","Pennsylvania","Pittsburg"],["Beth Israel Deaconess Medical Center","Sean Levy","美国","Massachusetts","Boston"],["The Johns Hopkins Hospital JHH","Stacey-Ann Brown","美国","Maryland","Baltimore"],["Columbia University Medical Center","Christina Eckhardt","美国","New York","New York"],["Malcom Randall VA Medical Center","Diana Gomez Manjarres","美国","Florida","Gainesville"],["Cleveland Clinic","Leslie Tolle","美国","Ohio","Cleveland"],["Central Florida Pulmonary Group","Ahmed Masood","美国","Florida","Orlando"],["Keck Medical Center of USC","Toby Maher","美国","California","Los Angeles"],["Weill Cornell Medicine","Anna Podolanczuk","美国","New York","New York"],["Cedars Sinai Medical Center","Tanzira Zaman","美国","California","West Hollywood"],["Northwestern Medical Group Gastroenterology","Catherine Myers","美国","Illinois","Chicago"],["Legacy Good Samaritan Hospital","Samuel Bullick","美国","Oregon","Portland"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["四川大学华西医院临床试验伦理审查委员会","同意","2024-08-19"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 86 ； 国际: 1113 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；