上海PF-07275315III期临床试验-一项在中度至重度长期呼吸困难（医学术语为慢性阻塞性肺疾病[COPD]）成人患者 中评估研究药物PF-07275315 的研究

登记号	CTR20261205	试验状态	进行中
申请人联系人	王磊沙	首次公示信息日期	2026-03-31
申请人名称	Pfizer Inc./ 辉瑞（中国）研究开发有限公司/ Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC

登记号	CTR20261205
相关登记号	暂无
药物名称	PF-07275315
药物类型	生物制品
临床申请受理号	企业选择不公示
适应症	中度至重度慢性阻塞性肺疾病
试验专业题目	一项研究PF-07275315 在成人中度至重度慢性阻塞性肺疾病(COPD) 研究参与者中的 疗效和安全性的干预性II/III 期、随机、双盲、第三方非盲、安慰剂对照、平行入组研 究
试验通俗题目	一项在中度至重度长期呼吸困难（医学术语为慢性阻塞性肺疾病[COPD]）成人患者 中评估研究药物PF-07275315 的研究
试验方案编号	C4531031	方案最新版本号	最终方案修正案1
版本日期:	2025-10-23	方案是否为联合用药	否

申请人名称	[["Pfizer Inc."],["辉瑞（中国）研究开发有限公司"],["Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC"]]
联系人姓名	王磊沙	联系人座机	010-85167022	联系人手机号	13552318872
联系人Email	Leisha.wang@pfizer.com	联系人邮政地址	北京市-北京市-朝阳门北大街3~7号五矿广场B座9层	联系人邮编	100010

本临床研究的目的是为了评估PF-07275315作为COPD患者潜在治疗方式的安全性和疗效。

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	35岁(最小年龄)至 80岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	[["根据当前 GOLD的定义，确诊 COPD 至少 1 年"],["Post-BD [FEV1]/[FVC] 比率 < 0.7 且 post-BD FEV1 ≥ 预测值的 30% 且 ≤ 预测值的 70%"],["在筛选访视 1 前 持续接受三联SOC治疗（LABA+LAMA + ICS）≥ 6 个月且在筛选访视 1 前 维持稳定剂量≥ 3 个月"],["在访视 1 前的过去 12 个月内有至少 2 次中度或重度 ECOPD 的病史记录"]]
排除标准	[["患有除COPD外的其他有临床意义的肺部疾病"],["需要通过鼻导管进行持续长期氧疗，氧流量 > 4.0 升/分钟"],["在呼吸环境空气时（或在研究参与者的常规补氧水平下）静息血氧 SpO2 < 88%"],["有临床意义的心血管疾病、急性和/或重度左心衰或射血分数保留性心力衰竭 (HFpEF) 和/或肺源性心脏病"]]

试验药	[["中文通用名:PF-07275315 英文通用名:PF-07275315 商品名称:NA","剂型:注射剂 规格:100mg/ml 用法用量:剂量1，皮下注射，依据方案给药频次进行给药；剂量2，皮下注射，依据方案给药频次进行给药；剂量3，皮下注射，依据方案给药频次进行给药。 用药时程:剂量1，24周；剂量2，24周；剂量3，52周。"]] 序号 名称 用法
对照药	[["中文通用名:PF-07275315安慰剂 英文通用名:PF-07275315placebo 商品名称:NA","剂型:注射剂 规格:0mg/ml 用法用量:皮下注射与相应实验组相匹配的剂量成分：组氨酸、蔗糖、PS80、精氨酸、EDTA 用药时程:Ⅱ期：24周；Ⅲ期：52周。"]] 序号 名称 用法

主要终点指标及评价时间

[["II期：第 24 周时与安慰剂相比 pre-BD FEV1 较基线的变化。","24周","有效性指标"],["III期：中度或重度 ECOPD 的年化发生率。","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

[["II期：中度或重度 ECOPD 的年化发生率","24周","有效性指标"],["II期：至第 24 周，pre-BD FEV1 较基线的变化","24周","有效性指标"],["II期：至第 24 周，pre-BD和post-BD 谷值 FEV1 较基线的变化","24周","有效性指标"],["II期：至第 24 周，pre-BD和post-BD谷值 FVC 和 FEV1/FVC 比率、预测 FEV1 %、预测 FVC % 较基线的变化","24周","有效性指标"],["II期：至第 24 周，谷值 FEV1 对 BD 的反应性较基线的变化","24周","有效性指标"],["II期：至第 24 周，研究的整个 II 期部分中 TEAE 的发生率和严重程度","24周","安全性指标"],["II期：至第 24 周，经治疗出现的 SAE 和导致停药的 TEAE 的发生率","24周","安全性指标"],["II期：临床异常的发生率以及临床实验室检查值、ECG 测量值和生命体征较基线的变化","24周","有效性指标+安全性指标"],["III期：第 12 周和第 52 周时 pre-BD 和post-BD FEV1 较基线的变化","52周","有效性指标"],["III期：第 52 周时 SGRQ 评分较基线改善 ≥ 4 分的研究参与者百分比","52周","有效性指标"],["III期：第 52 周时 CAT 总评分较基线改善 ≥ 2 分的研究参与者百分比","52周","有效性指标"],["III期：第 52 周时 E-RS:COPD 总评分较基线改善 ≥ 2 分的研究参与者百分比","52周","有效性指标"],["III期：重度 ECOPD 的年化发生率","52周","有效性指标"],["III期：需要急诊科就诊和/或住院的加重的年化发生率","52周","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	瞿介明	学位	医学博士	职称	主任医师
	电话	18800161180	Email	jmqu0906@163.com	邮政地址	上海市-上海市-瑞金二路197号上海交通大学医学院附属瑞金医院
	邮编	200025	单位名称	上海交通大学医学院附属瑞金医院

[["上海交通大学医学院附属瑞金医院","瞿介明","中国","上海市","上海市"],["中日友好医院","杨汀","中国","北京市","北京市"],["武汉市中心医院","胡轶","中国","湖北省","武汉市"],["广州医科大学附属第三医院","魏立平","中国","广东省","广州市"],["江西省人民医院","肖祖克","中国","江西省","南昌市"],["惠州市中心人民医院","陈中红","中国","广东省","惠州市"],["新乡市第一人民医院","张祥杰","中国","河南省","新乡市"],["安徽省胸科医院","方浩徽","中国","安徽省","合肥市"],["徐州医科大学附属医院","陈碧","中国","江苏省","徐州市"],["池州市人民医院","魏玉平","中国","安徽省","池州市"],["长沙市第一医院","汤渝玲","中国","湖南省","长沙市"],["成都市第五人民医院","刘晓","中国","四川省","成都市"],["重庆红十字会医院","傅铁军","中国","重庆市","重庆市"],["济南市中心医院","王欣","中国","山东省","济南市"],["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"],["浙江省台州医院","徐有祖","中国","浙江省","台州市"],["阜阳市人民医院","刘斌","中国","安徽省","阜阳市"],["内蒙古自治区人民医院","刘慧招","中国","内蒙古自治区","呼和浩特市"],["中南大学湘雅二医院","陈燕","中国","湖南省","长沙市"],["扬州大学附属医院","吴峰","中国","江苏省","扬州市"],["东南大学附属中大医院","张梅","中国","江苏省","南京市"],["上海市同济医院","余莉","中国","上海市","上海市"],["Infinity Medical Research","Dr.Curtis J. Mello","美国","MASSACHUSETTS","N Dartmouth"],["University of Kansas Medical Center","Dr.Mario Castro","美国","KANSAS","Kansas City"],["Sherman Clinical Research","Dr.Muqdad Abdalla Zuriqat","美国","TEXAS","Sherman"],["IKF Pneumologie Mainz","Prof.Stephanie Korn","德国","RHEINLAND-PFALZ","Mainz"],["Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf","Dr.Henrik Henrik Watz","德国","SCHLESWIG-HOLSTEIN","Grosshansdorf"],["Newport Native MD","Dr.Ryan M. Klein","美国","CALIFORNIA","Newport Beach"],["IMAX Clinical Trials","Dr.Andrew P. Morado","美国","CALIFORNIA","La Palma"],["C.I.C. Mauricie inc.","Dr.Pierre-Alexandre Menard","加拿大","QUEBEC","TROIS RIVIERES"],["IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardio","Dr.Marc Oliver Oliver Kornmann MD","德国","HESSEN","Frankfurt"],["Johns Hopkins Bayview Medical Center","Dr.Mark Chung-Hwa Liu","美国","MARYLAND","Baltimore"],["Renstar Medical Research","Dr.Raj Karunakara","美国","FLORIDA","Ocala"],["Temple University Hospital","Dr.Gerard Joseph Criner M.D.","美国","PENNSYLVANIA","philadelphia"],["Clinical Research Associates of Central PA","Dr.Sandeep Bansal","美国","PENNSYLVANIA","DuBois"],["Polikum Friedenau","Michael Sebert","德国","BERLIN","Berlin"],["Bradford Royal Infirmary","Dr.Dinesh Saralaya","英国","UNITED KINGDOM","Bradford"],["Flinders Medical Centre","Dr.Huw Richard Davies","澳大利亚","SOUTH AUSTRALIA","Adelaide"],["The Catholic University of Korea, Eunpyeong St. Mary’s Hospital","Prof.Sang Haak Lee","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["The Catholic Univ. of Korea Seoul St. Mary`s Hospital","Dr.Chin Kook Rhee","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Jeonbuk National University Hospital","Prof.SoRi Kim","韩国","JEONRABUGDO","Jeonju-si"],["Hospital de Merida","Luis Mateos Caballero","西班牙","BADAJOZ","Merida"],["Pneumologisch Onkologisch Internistisches Studienzentrum (POIS) Sachsen GmbH","Juliana Brode","德国","Leipzig","Leipzig"],["Inspiration Research","Dr.Kenneth Chapman","加拿大","ONTARIO","Toronto"],["Westmead Hospital","Stephen Milne","澳大利亚","NSW","Westmead"],["Konkuk University Medical Center","Kwang Ha Yoo","韩国","PUSAN-KWANGYǒKSHI","Seoul"],["Hospital Universitario Virgen de las Nieves","Dr.Bernardino Alcazar- Navarrete","西班牙","Granada","Granada"],["Hospital Internacional Xanit","Dr.Gustavo De luiz Martinez","西班牙","ANDALUCíA","Benalmadena"],["CPCC-RESEARCH LLC","Dr.NGOZIKA ORJIOKE","美国","GEORGIA","East Point"],["The Glenfield Hospital","Dr.Neil Greening","英国","LEICESTERSHIRE","Leicester"],["Hopital de la Croix Rousse","Prof.Gilles DEVOUASSOUX","法国","RHONE-ALPES","Lyon"],["SEC Clinical Research","Robert I Garver Jr","美国","ALABAMA","Dothan"],["Korea University Anam Hospital","Prof.SANG YEUB LEE Prof","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Hospital Universitario Miguel Servet","Marta Marin Oto","西班牙","Zaragoza","Zaragoza"],["Southeastern Research Center","Dr.Farhan Ahmed","美国","NORTH CAROLINA","Winston-Salem"],["Specialized Hospital for Active Treatment of Lung Diseases – Pernik EOOD","Dr.Galina Petrova","保加利亚","PERNIK","Pernik"],["IDIM – Instituto de Investigaciones Metabolicas","Dr.Ricardo Alfonso del Olmo Sansone","阿根廷","CIUDAD AUTONOMA DE BUENOS AIRES","Ciudad Autonoma de Buenos Aires"],["Medical Center","Prof.Dimo Mitev Dimov","保加利亚","STARA ZAGORA","Stara Zagora"],["Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Dr. Treiman","Mrs.Stella Dencheva Stefanova","保加利亚","VELIKO TARNOVO","Veliko Tarnovo"],["Infer-Med KFT Davinci Klinika","Dr.Marta Papp","匈牙利","BARANYA","Pecs"],["Erzsebet Gondozohaz","Dr.Janos Mucsi","匈牙利","PEST","Godollo"],["Hospital Universitario Virgen de la Victoria","Dr.Jose luis Velasco garrido","西班牙","MALAGA","Malaga"],["Hopital Arnaud de Villeneuve - CHU Montpellier","Dr.Arnaud Bourdin","法国","HERAULT","Montpellier"],["MEDITRIAL s.r.o.","Dr.Petr Kopecky","捷克","JIHOCESKY KRAJ","Jindichuv Hradec"],["FUNDACION CIDEA","Ms.Veronica Lawriwskyj","阿根廷","BUENOS AIRES","CABA"],["Medical Center Hera EOOD","Dr.Kiril Rashkov Palaveev Mr","保加利亚","SOFIA","Sofia"],["Pneumologie Varnsdorf s.r.o.","Dr.Milan Sklenar","捷克","USTECKY KRAJ","Varnsdorf"],["Nishifukuoka Hospital","Ritsuko Kunitake","日本","FUKUOKA","Fukuoka-Shi"],["Koch Robert Korhaz es Rendelointezet","Melinda Szabo","匈牙利","BORSOD-ABAUJ-ZEMPLEN","Edeleny"],["Szalay Janos Rendelointezet","Edina Kurucz","匈牙利","HAJDU-BIHAR","Hajdunanas"],["Guy`s & St Thomas` NHS Foundation Trust","Mona Bafadhel","英国","ENGLAND","London"],["Freeman Hospital","Nicholas Lane","英国","ENGLAND","Newcastle Upon Tyn"],["Hopitaux Universitaires Paris Centre-Hopital Cochin","Prof.Nicolas Roche","法国","PARIS","Paris"],["Velocity Clinical Research, Gaffney","Dr.David Richard Erb","美国","SOUTH CAROLINA","Gaffney"],["Hospital Universitario Marques de Valdecilla","Carlos Antonio Amado Diago","西班牙","CANTABRIA COMUNIDAD DE","Santander"],["Maharaja Agrasen Superspeciality Hospital","Dr.Manish Kumar Jain","印度","RAJASTHAN","Jaipur"],["Fundacion Respirar","Dr.Maria Cristina De Salvo","阿根廷","CIUDAD AUTONOMA DE BUENOS AIRES","Buenos Aires"],["Yamaguchi University Hospital","Tsunahiko Hirano","日本","YAMAGUCHI","Ube"],["Medical Center Pulmovision OOD","Dr.Miroslav Mihaylov","保加利亚","SOFIA","Sofia"],["SHATPPD Dr. Dimitar Gramatikov","Dr.Hristo Metev Metev","保加利亚","RUSE","Ruse"],["Kaohsiung Medical University Chung-Ho Memorial Hospital","Prof.Chau-Chyun Sheu","中国台湾","台湾","高雄"],["National Taiwan University Hospital","Dr.Jung-Yien Chien","中国台湾","台湾","台北"],["Ostrowieckie Centrum Medyczne spoka cywilna Anna Olech-Cudzik, Krzysztof Cudzik","Dr.Anna Iwona Olech-Cudzik","波兰","SWIETOKRZYSKIE","Ostrowiec Swietokrzyski"],["PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna","Dr.Grzegorz Jerzy Gasior Mr","波兰","SLASKIE","Sosnowiec"],["China Medical University Hospital","Dr.Chia-Hung Chen","中国台湾","台湾","台中"],["Taichung Veterans General Hospital","Prof.Pin-Kuei Fu","中国台湾","台湾","台中"],["Centrum Medyczne Pratia Bydgoszcz","Jacek Duleba","波兰","KUJAWSKO-POMORSKIE","Bydgoszcz"],["Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval (IUCPQ-UL)","Dr.Francois Maltais","加拿大","QUEBEC","Quebec"],["University General Hospital","Stelios Loukides","希腊","ATHENS","Athens"],["Sotiria Thoracic Diseases Hospital of Athens","Eleftherios Zervas","希腊","ATHENS","Athens"],["Asthama Bhavan","Dr.Sharad Tikkiwal","印度","RAJASTHAN","Jaipur"],["Hindusthan Hospital","Dr.Srikanth Krishnamurthy","印度","TAMILNADU","Coimbatore"],["MV Hospital and Research Centre","Dr.Sandeep Kumar Gupta","印度","UTTAR PRADESH","Lucknow"],["Shri Mahant Indiresh Hospital","Dr.Jagdish Kumar Rawat Professor","印度","UTTARAKHAND","Dehradun"],["Jawahar Lal Nehru Medical College","Dr.Piyush Arora","印度","RAJASTHAN","Ajmer"],["Bhaktivedanta Hospital and Research Institute","Dr.Ajay Madhav Godse","印度","MAHARASHTRA","Thane"],["Monash Health","Assoc. Prof.Philip Bardin","澳大利亚","VICTORIA","Clayton"],["University General Hospital of Heraklion","Dr.Nikolaos Tzanakis","希腊","HERAKLION","Heraklion"],["Mater Misericordiae Limited","Olivia Dixon","澳大利亚","QUEENSLAND","South Brisbane"],["Pectus Respiratory Health","Dr.Juan Roldan Sanchez","西班牙","BARCELONA","Barcelona"],["MHAT","Dr.Todor Atanasov","保加利亚","HASKOVO","Dimitrovgrad"],["Pulmonary Associates of Mobile, P.C.","Dr.Allan F. Seibert IV","美国","ALABAMA","Mobile"],["Linkou Chang Gung Memorial Hospital","Horng-Chyuan Lin","中国台湾","台湾","桃园"],["Ordinace chorob plicních","Dr.Zuzana Kovarikova","捷克","PRAHA 1","Praha"],["Washington University School of Medicine","Dr.James Krings","美国","MISSOURI","St. Louis"],["Instituto Ave Pulmo","Luis Wehbe","阿根廷","BUENOS AIRES","MAR DEL PLATA"],["Mudr.I.Cierna Peterova s.r.o.","Dr.Ivana Cierna Peterova","捷克","STREDOCESKY KRAJ","Brandys nad Labem"],["Klifeck GmbH","Dr.Gerald Eckhardt","德国","SACHSEN","Delitzsch"],["HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID","Jose Maria Maria Echave-Sustaeta Maria-Tome","西班牙","MADRID","Pozuelo de Alarcon"],["University General Hospital of Thessaloniki G. Papanikolaou","Konstantinos Porpodis","希腊","KENTRIKI MAKEDONIA","Thessaloniki"],["Far Eastern Memorial Hospital","Dr.Shih-Lung Cheng","中国台湾","台湾","新北市"],["Instituto medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion medica","Dr.FERNANDO ADRIAN MASSOLA","阿根廷","SANTA FE","Rosario"],["Medical Center Fama Medical","Blagoy Marinov","保加利亚","PLOVDIV","Plovdiv"],["KPPK Studienzentrum GmbH","Dr.Olaf Schmidt","德国","BENDORF","Bendorf"],["Omnimodus Elixír Kft.","Dr.Erika Unger","匈牙利","GYOR-MOSON-SOPRON","Mosonmagyarovar"],["Centrum Medyczne Pratia Katowice","Szymon Placzek","波兰","SLASKIE","Katowice"],["Lungenfachklinik Immenhausen","Dr.Peter Hammerl","德国","HESSEN","Immenhausen"],["Centro Medico de Enfermedades Respiratorias","Dr.Miguel Angel Bergna MD","阿根廷","BUENOS AIRES","Florida, Vicente Lopez"],["Instituto de Salud Respiratoria","Dr.Pedro Carlos Elías","阿根廷","MENDOZA","City"],["North Tyneside General Hospital","Stephen Christopher Bourke","英国","NORTH SHIELDS","North Shields"],["Centro Dr. Lazaro Langer","Victor Hugo Cambursano","阿根廷","CORDOBA","Cordoba"],["A.O.R.N. Ospedale dei Colli - Monaldi V.","Dr.andrea bianco","意大利","CAMPANIA","Napoli"],["Medicines Evaluation Unit","Prof.Dave Dave Singh","英国","MANCHESTER","Manchester"],["Centro de Investigaciones Medicas Althea","Andrea Cintia Medina","阿根廷","BUENOS AIRES","Villa Vatteone"],["Clinical Site Partners, LLC dba Flourish Research","Shirish Kirtane","美国","FLORIDA","Winter Park"],["Centre Hospitalier d`Annecy","Toufik Didi","法国","HAUTE-SAVOIE","Epagny Metz-Tessy"],["Pulmonary Associates, PA","Dr.Da-Wei Liao","美国","ARIZONA","Phoenix"],["THORACIC GENERAL HOSPITAL OF ATHENS","Petros Bakakos","希腊","ATHENS","Athens"],["University Hospital of Alexandroupolis","Prof.Paschalis Steiropoulos","希腊","ANATOLIKI MAKEDONIA KAI THRAKI","Alexandroupolis"],["University of Alabama at Birmingham","Raymond Wade","美国","ALABAMA","Birmingham"],["Greater Heights & Memorial Pulmonary and Sleep","Jose Melendez","美国","TEXAS","Houston"],["Azienda USL Reggio Emilia - Arcispedale Santa Maria Nuova (ASMN) - IRCCS","Anna Simonazzi","意大利","REGGIO EMILIA","Reggio Emilia"],["CenterMed Bandrowskiego","Malgorzata Zurowska-Gebala","波兰","TARNOW","Tarnow"],["Lungenzentrum Darmstadt","Andreas Forster","德国","DARMSTADT","Darmstadt"],["Horizon Clinical Research Group","Dileep Puppala","美国","TEXAS","Cypress"],["MCBK","Elzbieta Rybicka-Liszewska","波兰","PRUSZKOW","Pruszkow"],["Fifth MHAT EAD","Kalin Georgiev Aleksandrov","保加利亚","SOFIA","Sofia"],["National Taiwan University Hospital - Hsinchu branch","Dr.Chia-Lin Hsu","中国台湾","台湾","台北"],["Advanced Pulmonary Research Institute","Neal Warshoff","美国","FLORIDA","Loxahatchee"],["Centro de Investigaciones Medicas Mar del Plata","Manuel Naveyra","阿根廷","BUENOS AIRES","Mar del Plata"],["Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje","Dr.Tomas Dvorak","捷克","MLADA BOLESLAV","Mlada Boleslav"],["ETG Warszawa","Dr.Luiza Jonczak","波兰","MAZOWIECKIE","Warszawa"],["Toledo Institute of Clinical Research Inc.","Dr.Syed M Rehman","美国","OHIO","Toledo"],["Health Concepts","Dr.Richard Lee Beasley","美国","SOUTH DAKOTA","Rapid City"],["NHO Kinki Chuo Chest Medical Center","Dr.Toru Arai","日本","OSAKA","Sakai"],["Aso Iizuka Hospital","Dr.Kazunori Tobino","日本","FUKUOKA","Iizuka"],["AOU Policlinico umberto I","Matteo Bonini","意大利","ROMA","Roma"],["Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII","Fabiano Di Marco","意大利","BERGAMO","Bergamo"],["Azienda Ospedaliero Universitaria di Ferrara - Ospedale Sant'Anna","Alberto Papi","意大利","FERRARA","Cona"],["Premier Research Center, LLC","Dr.Clyde Southwell","美国","TENNESSEE","Hendersonville"],["Clinical Studies Pankow","Mr.Ishak Teber","德国","BERLIN","Berlin"],["UCLA Center for Health Sciences","Dr.Igor Barjaktarevic","美国","CALIFORNIA","Los Angeles"],["Nil Ratan Sircar Medical College an Hospital","Dr. Jaydip Deb","印度","WEST BENGAL","Kolkata"],["UNIVERSITY HOSPITAL OF PATRAS","Prof.Argyrios Tzouvelekis","希腊","ACHAIA","Rio"],["MEDICON","Dr.Vaclava Bartu","捷克","PRAHA 4","Praha 4"],["Hiroshima Prefectural Hospital","Nobuhisa Ishikawa","日本","HIROSHIMA","Hiroshimashi"],["Fujieda Municipal General Hospital","Naoki Koshimizu","日本","SHIZUOKA","Fujieda-shi"],["University of California Davis Health","Dr.Brooks Thomas Kuhn","美国","CALIFORNIA","Sacramento"],["National Hospital Organization Okinawa Hospital","Dr.Kenji Chibana","日本","OKINAWA","Ginowan"],["New York Presbyterian Queens","Anthony Smith","美国","NEW YORK","Flushing"],["Koujunkai Daido Clinic","Akinori Ishihara","日本","AICHI","Nagoya"],["Henderson Clinical Trials","Vikas Sayal","美国","NEVADA","Henderson"],["Centricity Research Rincon Pulmonology","Dr.Maria C. Mascolo","美国","GEORGIA","Rincon"],["Kure Kyosai Hospital","Shigeo Kawase","日本","HIROSHIMA","Kure"],["Tokyo Medical University Hachioji Medical Center","Prof.Kenji Tsushima","日本","TOKYO","Hachioji"],["Paul A.Shapero, M.D., PA","Paul A Shapero","美国","MAINE","Bangor"],["Southern Clinical Research, LLC","Dr.Ernest G. Thompson","美国","LOUISIANA","Zachary"],["Diamond Clinic","Dr.Barbara Rewerska","波兰","MALOPOLSKIE","Krakow"],["Pro Familia Altera","Dr.Danuta Barbara Wronska","波兰","SLASKIE","Katowice"],["Dobrostan Gabinet Lekarskie","Dr.Ewa Pisarczyk-Bogacka","波兰","DOLNOSLASKIE","Wroclaw"],["Synergy Medical Clinic","Dr.Dina Gaber Awad Fathy","加拿大","ALBERTA","Sherwood Park"],["Frankston Hospital","David Langton","澳大利亚","VIC","Frankston"],["South Texas Medical Research Institute, Inc., DBA TTS Research","Dr.David Fuentes","美国","TEXAS","Boerne"],["Genesis Clinical Research - Fall River","Dr.Daniel Franco Sousa","美国","MASSACHUSETTS","Fall River"],["California Medical Research Associates","Sanjay Vadgama","美国","CALIFORNIA","Northridge"],["Clinical Research of Rock Hill","Dr.Michael Denenberg","美国","SOUTH CAROLINA","Rock Hill"],["Layrek Clinical Research","Hassan Abouhouli","美国","OKLAHOMA","Tulsa"],["Medical Center Pulmo - 2018 EOOD","Veselin Todorov Kalfov","保加利亚","HASKOVO","Haskovo"],["Clinical Trials Center of Middle Tennessee","Alex J. Slandzicki","美国","TENNESSEE","Franklin"],["Oakland Medical Research","Dr.Jay H. Sandberg","美国","MICHIGAN","troy"],["Clinical Research Specialists","Dr.Fortune Alabi","美国","FLORIDA","Kissimmee"],["Medtrial, LLC","Dr.Carl Issac Mitchell","美国","SOUTH CAROLINA","Columbia"],["Finlay Medical Research","Dr.Jorge J Calle Medina","美国","FLORIDA","Greenacres"],["Clinical Research Trials of Florida, Inc.","Dr.Sady Armada Alpizar","美国","FLORIDA","Tampa"],["Reed Medical Research","Ariel Ramirez Navarro","美国","FLORIDA","Miami"],["ASHA Clinical Research - Munster, LLC","Raja G. Devanathan","美国","INDIANA","Hammond"],["Institute of HealthCare Assessment, Inc d/b/a Apex Clinical Research","Dr.Edward Charles Federman","美国","CALIFORNIA","San Diego"],["Bogan Sleep Consultants","Dr.Richard K. Bogan","美国","SOUTH CAROLINA","Columbia"],["Lenox Hill Hospital","Bushra Ayad Mina","美国","NEW YORK","Mount Kisco"],["Ashford and St Peter's Hospital NHS Foundation Trust","Dr.Monica Evelyn Nordstrom","英国","SURREY","Chertsey"],["Queen Anne Street Medical Centre","Dr.Brian R. Leaker","英国","CAMDEN","London"],["Coastal Pulmonary and Critical Care","Jose Francisco Luciano","美国","FLORIDA","Saint Petersburg"],["University of Utah","Dr.Cheryl Shannon Pirozzi","美国","UTAH","Salt Lake City"],["TrialsWest","Prof.Peter Reid Bremner","澳大利亚","WESTERN AUSTRALIA","Spearwood"],["Shree Hospital & Critical Care Center","Dr.Akash Lataru Balki","印度","MAHARASHTRA","Nagpur"],["Central Florida Pulmonary Group, PA","Mahmood Ali","美国","FLORIDA","Orlando"],["Revive Research Institute, Inc.","Syed Raza","美国","MICHIGAN","Southfield"],["Sir Ganga Ram Hospital","Dr.Amit Dhamija","印度","DELHI","New Delhi"],["Revive Research Institute, Inc.","Dr.Abdulhassan Saad","美国","MICHIGAN","Southfield"],["Glasgow Royal Infirmary","Hannah Bayes","英国","LANARKSHIRE","Glasgow"],["POLICLINICO","Prof.Carlo Vancheri","意大利","SICILIA","Catania"],["All India Institute of Medical Sciences","Dr.Vijay Hadda","印度","DELHI","New Delhi"],["Baylor Scott & White Health-Advanced Heart and Lung Disease","Dr.Mark W. Millard","美国","TEXAS","Dallas"],["San Paolo - ASST SANTI PAOLO E CARLO","Dr.Michele Mondoni","意大利","LOMBARDIA","Milano"],["Chandler Clinical Trials","Dr.Muhammad Salim","美国","ARIZONA","Chandler"],["Medizentrum Essen Borbeck","Dr.Axel Schaefer","德国","NORDRHEIN-WESTFALEN","Essen"],["Studienzentrum Dr. Keller","Dr.Claus Keller","德国","HESSEN","Frankfurt am Main"],["Dr. Syed Anees Medicine Professional Corporation","Dr.Syed Anees","加拿大","ONTARIO","Windsor"],["Private Practice - Dr. Christian Schlenska","Dr.Christian Schlenska","德国","NIEDERSACHSEN","Peine"],["Gemeinschaftspraxis Dres. Jung","Dr. med.Thomas Jung","德国","BADEN-WURTTEMBERG","Deggingen"],["Radhakrishna Multispecialty Hospital & IVF Centre","Dr.Vivek Gundappa","印度","KARNATAKA","Bangalore"],["Kamineni Hospitals - L.B.Nagar","Dr.Dr. Ravindra Reddy Etikala","印度","ANDHRA PRADESH","Hyderabad"],["KLE University - Belagavi","Dr. Jyothi Hattiholi","印度","KARNATAKA","Karnataka"],["Government Medical College","Suraj KP","印度","KERALA","Kozhikode"],["Velocity Clinical Research, Spartanburg","Dr.Luis Ignacio De La Cruz","美国","SOUTH CAROLINA","Spartanburg"],["Medical Advancement Centers of Arizona","Dr.Jeffrey R. Hoodin MD","美国","ARIZONA","Phoenix"],["Alina Clinical Trials","Dr.Barbara Stark Baxter","美国","TEXAS","Dallas"],["AA Medical Research Center","Dr.Ahmed Abdulmalik Arif","美国","MICHIGAN","Flint"],["TEN20 Clinical Research - Carrollton","Dr.Joseph Surdacki","美国","TEXAS","Carrollton"],["Wythenshawe Hospital","Dr.Thapas Nagarajan","英国","MANCHESTER","Manchester"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["上海交通大学医学院附属瑞金医院临床试验伦理委员会","同意","2026-01-28"]]

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: 140 ； 国际: 1056 ；
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：2026-02-11；
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；