北京注射用FelzartamabIII期临床试验-PREVAIL

登记号	CTR20253436	试验状态	进行中
申请人联系人	段文丽	首次公示信息日期	2025-08-27
申请人名称	不适用/ 天境生物科技（杭州）有限公司

登记号	CTR20253436
相关登记号	暂无
药物名称	注射用Felzartamab
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	免疫球蛋白 A 肾病 (IgAN)
试验专业题目	一项在 IgA 肾病成人患者中评价 Felzartamab 的随机、双盲、安慰剂对 照、III 期临床研究 (PREVAIL)
试验通俗题目	PREVAIL
试验方案编号	299IG301	方案最新版本号	V2.1
版本日期:	2025-02-13	方案是否为联合用药	否

申请人名称	[["不适用"],["天境生物科技（杭州）有限公司"]]
联系人姓名	段文丽	联系人座机	021-33072008	联系人手机号
联系人Email	wenli.duan@thermofisher.com	联系人邮政地址	上海市-上海市-徐汇区陕西南路288号20层2001、2008	联系人邮编	200031

主要目的： ●评估 felzartamab 与安慰剂相比对 IgAN 成人患者蛋白尿的疗效。 关键次要目的： ●评估 felzartamab 与安慰剂相比对 IgAN 成人患者肾功能的疗效。 其他次要目的： ●评估 felzartamab 与安慰剂相比对其他临床终点的疗效。 ●评估 felzartamab PK 和免疫原性。 探索性目的： ●评估 felzartamab 对探索性临床终点的疗效。 ● 评估 felzartamab 对 IgAN 相关生物标志物的影响。 ● 评估 felzartamab 对患者报告结局的影响。 安全性目的： ● 评估 felzartamab 与安慰剂相比的安全性和耐受性。

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	18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	[["在 ICF 签署前 10 年内通过组织活检确诊患有 IgAN。对于 2 型糖尿病参与者，必须在签署 ICF 前 24 个月内通过组织活检确诊 IgAN。"],["筛选时使用 2021 年 CKD-EPI 肌酐公式计算的 eGFR ≥ 30 mL/min/1.73m2。对于探索性队列，eGFR 可以为 ≥ 20 且 < 30 mL/min/1.73m2"],["通过筛选期间采集的足量 24 小时尿液进行评估，蛋白尿 ≥ 1.0 g/天或 UPCR ≥ 0.8 g/g"],["筛选前接受最大耐受剂量或最大批准剂量的血管紧张素转换酶抑制剂 (ACEI) 或血管紧张素受体阻滞剂 (ARB) 达到临床稳定至少 12 周，或对 ACEI 或 ARB 不耐受。如果不耐受，必须在随机分配前与医学监查员讨论。参与者也可能正在使用钠-葡萄糖协同转运蛋白-2 抑制剂 (SGLT2is)、已获批用于治疗 IgAN 的内皮素受体拮抗剂 (ERA)，和/或盐皮质激素受体拮抗剂 (MRA)，前提是在筛选前剂量保持稳定至少 12 周。在研究期间，参与者应保持使用稳定剂量的此类背景药物。ICF 签署后，研究期间不得更改剂量，亦不得停药，但因 AE 而认为有必要更改剂量或停药的情况除外。使用 sparsentan 的参与者不得同时使用 ACEI 或 ARB 药物。"]]
排除标准	[["经研究者确定的继发性 IgAN，表现为存在可能导致 IgA 沉积的任何其他系统性疾病。"],["快速进展的病变型 IgAN 史，定义为每 3 个月 eGFR 下降 > 50%，且不能用 RAS 阻断的变化或其他因素来解释。"],["推测微小病变(MCD )变异引起的肾病综合征。"],["合并患有其他进行性肾小球肾炎或非免疫性肾小球疾病，如糖尿病肾病。"],["患有 2 型糖尿病，且筛选时血红蛋白 A1c (HbA1c) > 8%，或组织活检显示有糖尿病肾病的证据，有糖尿病性微血管或大血管疾病史。"],["任何确诊或疑似免疫抑制或免疫缺陷状态，如无脾、HIV、原发性免疫缺陷、器官或骨髓移植，但角膜移植除外。"],["曾接受过免疫抑制剂或其他免疫调节剂治疗，包括但不限于环磷酰胺、利妥昔单抗、英夫利西单抗、依库珠单抗、canakinumab、MMF 或麦考酚钠 (MPS)、环孢素、他克莫司、西罗莫司、依维莫司或全身性皮质类固醇暴露（> 7.5 mg/天泼尼松/泼尼松龙当量）。"],["筛选前 4 个月（对于利妥昔单抗，则为 12 个月）内使用过等效的泼尼松/泼尼松龙当量。"],["目前正在接受口服布地奈德治疗的参与者。筛选前 ≥ 4 个月停止接受此治疗的患者可能有资格参加本研究。"],["有临床意义的活动性感染，或已知有临床意义的复发性感染史， 或筛选时存在与活动性感染相符的实验室证据，或接受过 IV 抗感染（抗菌药物、抗病毒药物或抗真菌药物）治疗，有机会性感染史的参与者需被排除。"],["低丙种球蛋白血症：筛选时血清 IgG < 6.0 g/L。"]]

试验药	[["中文通用名:NA 英文通用名:Felzartamab（又称MOR202、MOR03087、TJ202、HIB202和BIIB148） 商品名称:NA","剂型:注射剂 规格:325mg 用法用量:体重≤50kg，Felzartamab使用650mg;体重>50至70kg，Felzartamab使用975mg;>70至90kg，Felzartamab使用1300mg；体重>90kg，Felzartamab使用1625mg. 用药时程:受试者将接受Felzartamab静脉（IV）输注。治疗期将持续24周"]] 序号 名称 用法
对照药	[["中文通用名:0.9%生理盐水 英文通用名:0.9%salinesolution 商品名称:NA","剂型:注射剂 规格:0.9%氯化钠 用法用量:根据Felzartamab公斤体重要求使用相同体积生理盐水 用药时程:受试者将接受安慰剂静脉（IV）输注。治疗期将持续24周。"]] 序号 名称 用法

主要终点指标及评价时间

[["基于 24 小时尿液采集，通过 UPCR 测量的蛋白尿 从基线到第 36 周的变化百分比。","从基线到第 36 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

[["eGFR 从基线到第 104 周的变化，eGFR 值使用 CKD-EPI 肌酐公式 (CKD-EPI 2021) 计算。","从基线到第 104 周","有效性指标"],["在第 104 周，实现 CR< 0.5 g/g、UPCR 降幅 ≥ 50% 且eGFR 稳定 [eGFR 较基线降低 ≤ 25%]）的参与者比 例。","从基线到第 104 周","有效性指标"],["需要补救治疗的参与者比例。","从基线到第 104 周","有效性指标"],["eGFR 从基线到第 52 周的变化，eGFR 值使用 CKD-EPI 肌酐公式计算","从基线到第 52 周","有效性指标"],["随时间变化的 felzartamab 血清浓度。","在给药前和给药后多个时间点直到第36周","有效性指标"],["血清中抗 felzartamab ADA 的基线患病率，以及基 线后的发生率随时间的变化。","从基线到第 104 周","有效性指标"],["TEAE 发生率和频率，按严重程度、级别、严重 性、与研究药物的相关性以及 AESI 划分。将对研 究中发生的 AE 进行类似分析。","从基线到第 104 周","安全性指标"],["生命体征、相关实验室参数、ECG 和体格检查较基线的变化。","从基线到第 104 周","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	吕继成	学位	医学博士	职称	主任医师
	电话	010-83575530	Email	jichenglv75@gmail.com	邮政地址	北京市-北京市-西城区西什库大街8号
	邮编	100034	单位名称	北京大学第一医院

[["北京大学第一医院","吕继成","中国","北京市","北京市"],["北京大学深圳医院","侯霜","中国","广东省","深圳市"],["北京清华长庚医院","李月红","中国","北京市","北京市"],["复旦大学附属华山医院","张敏","中国","上海市","上海市"],["山东大学第二医院","柳刚","中国","山东省","济南市"],["中山大学孙逸仙纪念医院","杨琼琼","中国","广东省","广州市"],["河北医科大学第二医院","李绍梅","中国","河北省","石家庄市"],["无锡市人民医院","刘斌","中国","江苏省","无锡市"],["广西医科大学第一附属医院","杨桢华","中国","广西壮族自治区","南宁市"],["上海市第一人民医院","范秋灵","中国","上海市","上海市"],["阜阳市人民医院","李小伟","中国","安徽省","阜阳市"],["上海市嘉定区中心医院","曹励欧","中国","上海市","上海市"],["金华市中心医院","黄坚","中国","浙江省","金华市"],["中国医科大学附属盛京医院","周华","中国","辽宁省","沈阳市"],["浙江省台州医院","徐光标","中国","浙江省","台州市"],["四川省医学科学院·四川省人民医院","李贵森","中国","四川省","成都市"],["沧州市中心医院","孙福云","中国","河北省","沧州市"],["山东大学齐鲁医院","杨向东","中国","山东省","济南市"],["南通大学附属医院","黄新忠","中国","江苏省","南通市"],["宜昌市中心人民医院","杨林","中国","湖北省","宜昌市"],["河南科技大学第一附属医院","王俊霞","中国","河南省","洛阳市"],["武汉大学人民医院","杨定平","中国","湖北省","武汉市"],["厦门大学附属中山医院","高清","中国","福建省","厦门市"],["甘肃省人民医院","黄文辉","中国","甘肃省","兰州市"],["大庆油田总医院","张洪波","中国","黑龙江省","大庆市"],["烟台毓璜顶医院","李鹏","中国","山东省","烟台市"],["南京医科大学第二附属医院","何伟春","中国","江苏省","南京市"],["贵州医科大学附属医院","严瑞","中国","贵州省","贵阳市"],["厦门大学附属第一医院","邵乐平","中国","福建省","厦门市"],["中山市中医院","李燕林","中国","广东省","中山市"],["福建医科大学附属协和医院","魏立新","中国","福建省","福州市"],["广西壮族自治区人民医院","熊礼佳","中国","广西壮族自治区","南宁市"],["复旦大学附属中山医院","丁小强","中国","上海市","上海市"],["安徽医科大学第一附属医院","吴永贵","中国","安徽省","合肥市"],["河北医科大学第三医院","迟雁青","中国","河北省","石家庄市"],["贵州省人民医院","查艳","中国","贵州省","贵阳市"],["南方医科大学深圳医院","郭啸华","中国","广东省","深圳市"],["广州医科大学附属第一医院","肖洁","中国","广东省","广州市"],["UCLA Health Connie Frank Kidney Transplant Center and General Nephrology","Rastogi, Anjay","美国","California","Los Angeles"],["Prolato Clinical Research Center","Workeneh, Biruh","美国","Texas","Houston"],["Royal Research, Corp - Hollywood","Torres, Elio","美国","Florida","Hollywood"],["Vista Del Mar Medical Group, Inc. - HyperCore - PPDS","Mortazavi, Koosha","美国","California","Oxnard"],["Fundacion de Investigacion de Diego (FDI Clinical Research) - Alcanza (San Juan) - HyperCore - PPDS","Cangiano-Rivera, Jose","美国","San Juan","San Juan"],["Knoxville Kidney Center, PLLC - Frenova F1","Newman, George","美国","Tennessee","Knoxville"],["Kidney & Hypertension Center","Vera Tapia, Edgard","美国","California","Apple Valley"],["Masters of Clinical Research Inc - 1232 Augusta West Parkway","Sprague, Amy","美国","Georgia","Augusta"],["R & H Clinical Research-777 S Fry Rd","Hussain, Syed","美国","Texas","Katy"],["Brigham and Women's Hospital -75 Francis Street","McCausland, Finnian","美国","Massachusetts","Boston"],["International Medical Clinic, PLLC","Al-Saghir, Fahd","美国","Michigan","Pontiac"],["Central Florida Kidney Specialists","Madan, Arvind","美国","Florida","Orlando"],["American Clinical Trials LLC","Nweke, Chinedu","美国","Georgia","Acworth"],["Lifespan at Rhode Island Hospital","Tang, Jie","美国","Rhode Island","Providence"],["Applied Research Center of Arkansas - 1701 Aldersgate Rd - HyperCore- PPDS","Heifner, John","美国","Arkansas","Little Rock"],["California Kidney Specialists","Jamal, Aamir","美国","California","San Dimas"],["Texas Kidney Institute - Dallas","Kumar, Sumit","美国","Texas","Dallas"],["James J Peters Veterans Administration Medical Center - NAVREF - PPDS","Xu, Chang","美国","New York","Bronx"],["Scripps Health","Harper, Kimberly","美国","California","La Jolla"],["Midwest Nephrology Associates,Inc.","Singer, Gary","美国","Missouri","Saint Peters"],["University of Florida - Gainesville - 1600 SW Archer Rd","Lau, Wai","美国","Florida","Gainesville"],["Nova Clinical Research, LLC","Toka, Hakan","美国","Florida","Bradenton"],["Penn Renal Electrolyte and Hypertension Perelman","Coppock, Gaia","美国","Pennsylvania","Philadelphia"],["Massachusetts General Hospital","Seethapathy, Harish","美国","Massachusetts","Boston"],["Vancouver Coastal Health Research Institute","Barbour, Sean","加拿大","British Columbia","Vancouver"],["McGill University Health Centre (MUHC)","Suri, Rita","加拿大","Quebec","Montreal"],["Consultorios Médicos Dr. Doreski - PPDS","De Francesco, Juan Aurelio","阿根廷","Buenos Aires","Ciudad Autónoma de Buenos Aires"],["CIMER-Centro Integral de Medicina Respiratoria","Alonso, Santiago Javier","阿根廷","Tucumán","San Miguel de Tucumán"],["Hospital Italiano de Buenos Aires","Varela, Carlos","阿根廷","Buenos Aires","Ciudad Autónoma de Buenos Aires"],["Hospital General de Agudos Dr. Cosme Argerich","Ra？o, Julieta","阿根廷","Buenos Aires","Ciudad Autónoma de Buenos Aires"],["DOM Centro de Reumatología","Korman Turk, Laurencia","阿根廷","Buenos Aires","Ciudad Autónoma de Buenos Aires"],["INECO Neurociencias Oro？o","Miralles, Dana","阿根廷","Santa Fe","Rosario"],["Hospital das Clínicas da Faculdade de Medicina da Universidade de S？o Paulo","Noronha, Irene","巴西","Sao Paulo","Sao Paulo"],["Hospital de Clinicas de Porto Alegre (HCPA) - PPDS","Karohl, Cristina","巴西","Rio Grande do Sul","Porto Alegre"],["Freire Pesquisa Clínica","Do Carmo Milagres, Rosangela","巴西","Minas Gerais","Belo Horizonte"],["Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS","Macedo de Souza, Pedro Augusto","巴西","Minas Gerais","Belo Horizonte"],["Hospital Alemao Oswaldo Cruz (HAOC)","Sato, Victor","巴西","Sao Paulo","Sao Paulo"],["Fundacao Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde","Da Silva Selistre, Luciano","巴西","Rio Grande do Sul","Caxias do Sul"],["Nephron Assistencia Nefrologica","Watanabe, Renato","巴西","Sao Paulo","Sao Paulo"],["Centro Mineiro de Pesquisa - CMiP","Barros do Carmo, Wander","巴西","Minas Gerais","Juiz De Fora"],["Clinica de la Costa Ltda - PPDS","Cadena Bonfanti, Andrés","哥伦比亚","Barranquilla","Barranquilla"],["Hospital Universitario San Ignacio","Contreras Villamizar, Kateir Mariel","哥伦比亚","Cundinamarca","Bogota"],["Fundacion Valle Del Lili","Schweineberg Lopez, Johanna","哥伦比亚","Valle del Cauca","Cali"],["Hospital Alma Máter de Antioquia","Gomez Villalobos, Juan Sebastian","哥伦比亚","Antioquia","Medellin"],["Fundacion Santa Fe de Bogotá","Guzman Ruiz, Gustavo Adolfo","哥伦比亚","Cundinamarca","Bogotá"],["Healthy Medical Center S.A.S.","Hurtado Uriarte, Maite","哥伦比亚","Cundinamarca","Zipaquira"],["Fundacion Cardiovascular de Colombia - KM 7 Autopista","Pena Wilches, Adalberto","哥伦比亚","Santander","PIEDECUESTA"],["Charité - Universitatsmedizin Berlin","Schrezenmeier, Eva","德国","Berlin","Berlin"],["Universitatsklinikum Carl Gustav Carus an der TU Dresden","Hugo, Christian","德国","Sachsen","Dresden"],["Universitatsklinikum Leipzig","Kowald, Jan","德国","Leipzig","Leipzig"],["Universitatsklinikum Ulm","Schulte-Kemna, Lena","德国","Baden","Württemberg- Ulm"],["Universitatsklinikum Heidelberg","Zeier, Martin","德国","Baden-Württemberg","Heidelberg"],["Universitatsklinikum Frankfurt","Lang, Jeannine","德国","Frankfurt am Main","Frankfurt am Main"],["Nephrologisches Zentrum Villingen-Schwenningen","Hohenstein, Bernd","德国","Villingen","Schwenningen"],["Universitatsmedizin der Johannes Gutenberg-Universit？t Mainz","Weinmann-Menke, Julia","德国","Rheinland-Pfalz","Mainz"],["LMU Klinikum der Universitat München - Campus Groβhadern","Fischereder, Michael","德国","München","München"],["CHU de Bordeaux - Hospital Pellegrin","Rigothier, Claire","法国","Gironde","Bordeaux"],["CHU de Nimes - Hopital Universitaire Caremeau","Moranne, Olivier","法国","Nimes","Nimes"],["CHU Amiens Picardie - Site Sud","Choukroun, Gabriel","法国","Somme","Amiens"],["GHRMSA - Hospital Emile Muller","Chantrel, Francois","法国","Mulhouse","Mulhouse"],["AP-HP - Hospital de la Pitié Salpétrière","El Karoui, Khalil","法国","Paris","Paris"],["AP-HP - Hospital Saint-Louis","Pillebout, Evangeline","法国","Paris","Paris"],["CHU de Strasbourg - Nouvel Hospital Civil","Duval, Anna","法国","Strasbourg","Strasbourg"],["AP-HP - Hospital Henri Mondor","Audard, Vincent","法国","Val-de-Marne","Créteil"],["CHU de Reims - Hospital Maison Blanche","Verdier, Vincent","法国","Reims","Reims"],["Centre Hospitalier de La Roche-sur-Yon","Ronsin, Charles","法国","La Roche-sur-Yon","La Roche-sur-Yon"],["Hopital Foch","Jalal Eddine, Arwa","法国","Suresnes","Suresnes"],["CHU de Besancon","Chabannes, Melchior","法国","Doubs","Besancon"],["CHRU d'Orleans- Hospital de La Source","Dekeyser, Manon","法国","Orléans","Orléans"],["Azienda Ospedaliero Universitaria di Parma","Delsante, Marco","意大利","Emilia-Romagna","Parma"],["Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò","Trillini, Matias","意大利","Ranica","Ranica"],["Ospedale Policlinico San Martino IRCCS","Esposito, Pasquale","意大利","Liguria","Genova"],["Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale Maggiore","Di Maso, Vittorio","意大利","Friuli-Venezia Giulia","Trieste"],["Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena","Magistroni, Riccardo","意大利","Emilia-Romagna","Modena"],["AUSL Piacenza - Ospedale Guglielmo da Saliceto","Scarpioni, Roberto","意大利","Piacenza","Piacenza"],["IRCCS Istituto Clinico Humanitas","Moroni, Gabriella","意大利","Lombardia","Rozzano"],["ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia","Alberici, Federico","意大利","Lombardia","Brescia"],["ASL Salerno - Presidio Ospedaliero Maria SS Addolorata","Gigliotti, Giuseppe","意大利","Campania","Eboli"],["ASL Città di Torino - Ospedale San Giovanni Bosco","Fenoglio, Roberta","意大利","Piemonte","Torino"],["Azienda Ospedaliero Universitaria Maggiore della Carità","Cantaluppi, Vincenzo","意大利","Piemonte","Novara"],["ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda","Minetti, Enrico","意大利","Milano","Milano"],["Azienda Ospedaliero Universitaria Consorziale Policlinico","Gesualdo, Loreto","意大利","Puglia","Bari"],["Hospital Universitario Vall d'Hebron - PPDS","Soler Romeo, Maria Jose","西班牙","Barcelona","Barcelona"],["Hospital Universitario Miguel Servet","Gracia Garcia, Olga","西班牙","Zaragoza","Zaragoza"],["Hospital del Mar","Rodriguez Garcia, Eva","西班牙","Barcelona","Barcelona"],["Hospital Universitari de Girona Dr Josep Trueta","Martin Alemany, Nadia","西班牙","Girona","Girona"],["Hospital Universitario de Getafe","Martins Munoz, Judith Fatima","西班牙","Madrid","Getafe"],["Hospital Universitario A Coruna","Rodriguez Magarinos, Catuxa","西班牙","a Coruna","a Coruna"],["Fundacio Puigvert","Marco Rusi？ol, Helena","西班牙","Barcelona","Barcelona"],["Hospital Universitario Virgen Macarena","Salgueira Lazo, Mercedes","西班牙","Sevilla","Sevilla"],["Hospital San Pedro de Alcantara","Labrador Gomez, Pedro Jesus","西班牙","Cáceres","Centro"],["Hospital Universitario Fundacion Alcorcon","Lopez Melero, Eva","西班牙","Madrid","Alcorcon"],["Hospital Universitario Fundacion Jimenez Diaz","Ortiz Arduan, Alberto","西班牙","Madrid","Madrid"],["Hospital Universitario 12 de Octubre","Gutierrez Martinez, Eduardo","西班牙","Madrid","Madrid"],["Royal Stoke University Hospital","Wessels, Diane (Julie)","英国","Staffordshire","Stoke-On-Trent"],["Leicester General Hospital","Cheung, Chee Kay","英国","Leicestershire Leicester","Leicestershire Leicester"],["Northern General Hospital","Khwaja, Salim Arif","英国","South Yorkshire Sheffield","South Yorkshire Sheffield"],["Royal Preston Hospital - NWCRN- PPDS","Ponnusamy, Arvind","英国","Lancashire Preston","Lancashire Preston"],["Pomorski Uniwersytet Medyczny w Szczecinie","Ciechanowski, Kazimierz","波兰","Zachodniopomorskie Szczecin","Zachodniopomorskie Szczecin"],["TWOJA PRZYCHODNIA – SZCZECINSKIE CENTRUM MEDYCZNE","Bobrek-Lesiakowska, Katarzyna","波兰","Zachodniopomorskie Szczecin","Zachodniopomorskie Szczecin"],["SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251","Nowicki, Michal","波兰","Lodz","Lodz"],["SCM Clinic - Prywatny Szpital Specjalistyczny","Aksamit, Dariusz","波兰","Malopolskie Kraków","Malopolskie Kraków"],["MCM Krakow - PRATIA - PPDS","Miarka, Przemyslaw","波兰","Malopolskie Kraków","Malopolskie Kraków"],["Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17","Lizakowski, Slawomir","波兰","Pomorskie Gdansk","Pomorskie Gdansk"],["ZOL Genk - campus Sint-Jan","Sprangers, Ben","比利时","Pomorskie Gdansk","Pomorskie Gdansk"],["Cliniques Universitaires Saint-Luc - PPDS","Demoulin, Nathalie","比利时","Brussels Brussels","Brussels Brussels"],["Hospital Erasme - PPDS","Van Meerhaeghe, Tess","比利时","Brussels Anderlecht","Brussels Anderlecht"],["Jan Yperman","Terryn, Wim","比利时","West-Vlaanderen Ieper","West-Vlaanderen Ieper"],["AZ Groeninge","Doubel, Peter","比利时","Kortrijk","Kortrijk"],["UZ Leuven - PPDS","Claes, Kathleen","比利时","Vlaams Brabant Leuven","Vlaams Brabant Leuven"],["ULS de Gaia/Espinho, EPE - Unidade I","Gomes, Ana","葡萄牙","Vila Nova de Gaia","Vila Nova de Gaia"],["ULS da Regiao de Aveiro, EPE - Hospital Infante D. Pedro","Vidinha, Joana","葡萄牙","Aveiro","Aveiro"],["Centro Clínico Académico, Braga - Hospital de Braga","Vaz, Raquel","葡萄牙","Braga Braga","Braga Braga"],["ULS de Lisboa Ocidental, EPE - Hospital Santa Cruz","Birne, Rita","葡萄牙","Carnaxide","Carnaxide"],["ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra","Ferreira, Emanuel","葡萄牙","Coimbra Coimbra","Coimbra Coimbra"],["ULS da Regiao de Leiria, EPE - Hospital de Santo André","Silva, Joana","葡萄牙","Leiria Leiria","Leiria Leiria"],["ULS da Arrábida, EPE - Hospital de Sao Bernardo","Farinha, Ana","葡萄牙","Setúbal Setúbal","Setúbal Setúbal"],["Vseobecna Fakultni Nemocnice V Praze","Tesar, Vladimir","捷克","Praha","Praha"],["Institut klinicke a experimentalni mediciny","Viklicky, Ondrej","捷克","Praha","Praha"],["Laiko General Hospital of Athens","Marinaki, Smaragdi","希腊","Attiki","Athens"],["AHEPA University General Hospital of Thessaloniki","Liakopoulos, Vassilios","希腊","Thessaloniki","Thessaloniki"],["University General Hospital ''ATTIKON''","Lionaki, Sophia","希腊","Attiki","Chaidari"],["General Hospital of Heraklion Venizeleio''","Xydakis, Dimitris","希腊","Irakleio","Heraklion"],["General Hospital of Athens ''Hippokratio''","Petras, Dimitrios","希腊","Attiki","Athens"],["PAGNI-University General Hospital of Heraklion","Stylianou, Konstantinos","希腊","Irakleio","Heraklion"],["General Hospital of Athens ''G. Gennimatas''","Moustakas, Georgios","希腊","Attiki","Athens"],["General Hospital of Thessaloniki ''G. Papanikolaou''","Bamichas, Gerasimos","希腊","Thessaloniki","Exochi-Chortiatis"],["General Hospital of Arta","Gouva, Chariklia","希腊","Arta","Arta"],["Ankara Bilkent Sehir Hastanesi","Dede, Fatih","土耳其","Ankara","Bilkent"],["Kocaeli Universitesi Arastirma ve Uygulama Hastanesi","Eren, Necmi","土耳其","Kocaeli","Kocaeli"],["Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi","Turkmen, Kultigin","土耳其","Konya","Konya"],["Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi Hastanesi","Seyahi, Nurhan","土耳其","Istanbul","Istanbul"],["Erciyes Universitesi Tip Fakultesi Gevher Nesibe Hastanesi","Kocyigit, Ismail","土耳其","Kayseri","Kayseri"],["Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi","Arikan, Izzet","土耳其","Istanbul","Istanbul"],["Medical Center Hera EOOD, Montana","Dimitrova, Irena","保加利亚","Montana","Montana"],["Medical Center Medconsult Pleven OOD","Garev, Lazar","保加利亚","Pleven","Pleven"],["Medical Center Medconsult Pleven - Lovech Branch","Vasileva, Diana","保加利亚","Lovech","Lovech"],["University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD-15 Acad. Ivan Geshov Blvd","Kundurdjiev, Atanas","保加利亚","Sofia","Sofia"],["University Multiprofile Hospital for Active Treatment Sveta Anna","Bogov, Boris","保加利亚","Sofia","Sofia"],["Special Hospital Medico","Vujicic, Bozidar","克罗地亚","Rijeka","Rijeka"],["Clinical Hospital Center Rijeka - PPDS","Bubic, Ivan","克罗地亚","Rijeka","Rijeka"],["Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29","Gulin, Tonko","克罗地亚","Grad Zagreb","Zagreb"],["Poliklinika Bonifarm-Hondlova 2/10","Vukovic Brinar, Ivana","克罗地亚","Grad Zagreb","Zagreb"],["Westmead Hospital","Phoon, Richard","澳大利亚","New South Wales","Westmead"],["Sunshine Hospital - Australia","Pedagogos, Eugenia","澳大利亚","Victoria","St Albans"],["Townsville Hospital","Srivastava, Vikas","澳大利亚","Queensland","Douglas"],["John Hunter Hospital","Chacko, Bobby","澳大利亚","New South Wales","New Lambton"],["Royal Brisbane & Women's Hospital","O'Sullivan, Eoin","澳大利亚","Queensland","Herston"],["Gold Coast University Hospital","Kurtkoti, Jagadeesh","澳大利亚","Queensland","Southport"],["Concord Repatriation General Hospital","Wong, Muh Geot","澳大利亚","New South Wales","Concord"],["Ajou University Hospital","Park, Inwhee","韩国","Gyeonggido","Suwon-si"],["Seoul National University Hospital","Park, Sehoon","韩国","Seoul Teugbyeolsi","Seoul"],["Inje University Haeundae Paik Hospital","Park, Sihyung","韩国","Gwangyeogsi Busan","Busan"],["Pusan National University Hospital","Song, Sang Heon","韩国","Busan Gwangyeogsi","Busan"],["Seoul National University Bundang Hospital","Park, Seokwoo","韩国","Gyeonggido","Seongnam-si"],["Hallym University Sacred Heart Hospital","Kim, SungGyun","韩国","Gyeonggido","Anyang-si"],["Samsung Medical Center","Lee, Jung Eun","韩国","Seoul Teugbyeolsi","Seoul"],["Severance Hospital Yonsei University Health System","Han, Seung Hyeok","韩国","Seoul Teugbyeolsi","Seoul"],["Far Eastern Memorial Hospital","Peng, Yu-Sen","中国台湾","台湾省","新台北"],["Mackay Memorial Hospital-Taipei branch","Wu, Pei-Chen","中国台湾","台湾省","台北"],["Chang Gung Memorial Hospital, Linkou","Chen, Kuan-Hsing","中国台湾","台湾省","桃园"],["China Medical University Hospital - PPDS","Lai, Ping-Chin","中国台湾","台湾省","台中市"],["Taipei Municipal Wanfang Hospital","Cheng, Chung-Yi","中国台湾","台湾省","台北"],["Kaohsiung Medical University - Chung-Ho Memorial Hospital","Chiu, Yi-Wen","中国台湾","台湾省","高雄"],["National Cheng Kung University Hospital","Sung, Junne-Ming","中国台湾","台湾省","台南"],["Taipei Medical University Shuang Ho Hospital","Wu, Mai-Szu","中国台湾","台湾省","新台北"],["Auckland City Hospital-Victoria Street West","Goh, Tze","新西兰","Auckland","Auckland"],["Aotearoa Clinical Trials Trust- Middlemore Hospital","Jayanatha, Kalpa","新西兰","Auckland","Papatoetoe"],["Wellington Hospital","Chembo, Caroline","新西兰","Wellington","Wellington"],["Waikato Hospital","Rabindranath, Kannaiyan","新西兰","Waikato","Hamilton"],["University Malaya Medical Centre","Lim, Soo Kun","马来西亚","Kuala Lumpur","Kuala Lumpur"],["Hospital Raja Permaisuri Bainun","Thong, Kah Mean","马来西亚","Ipoh","Ipoh"],["Hospital Tengku Ampuan Afzan","Mohamad Nor, Fariz Safhan","马来西亚","Pahang","Kuala Kuantan"],["SMS Superspeciality Hospital","Agrawal, Dhananjai","印度","Rajasthan","Jaipur"],["Sir Ganga Ram Hospital","Gupta, Anurag","印度","Delhi","New Delhi"],["Nil Ratan Sircar Medical College and Hospital","Mukhopadhyay, Pinaki","印度","West Bengal","Kolkata"],["Zydus Hospital","Goplani, Kamal","印度","Gujarat","Ahmedabad"],["Muljibhai Patel Society for Research in Nephro-Urology","Gang, Sishir","印度","Gujarat","Nadiad"],["All India Institute of Medical Sciences ( AIIMS ) - Raipur","Rathore, Vinay","印度","Chhattisgarh","Raipur"],["Seth G S Medical College and K E M Hospital","Jamale, Tukaram","印度","Maharashtra","Mumbai"],["Max Super Speciality Hospital - Saket","Khullar, Dinesh","印度","Delhi","New Delhi"],["Osmania General Hospital","Sahay, Manisha","印度","Andhra Pradesh","Hyderabad"],["Nizams Institute of Medical Sciences","Raju, D. Sree","印度","Andhra Pradesh","Hyderabad"],["Noble Hospital","Ignatius, Avinash","印度","Maharashtra","Pune"],["Manipal Hospital Bangalore","Siddini, Vishwanath","印度","Karnataka","Bangalore"],["Christian Medical College - Ranipet Campus","Alexander, Suceena","印度","Tamil Nadu","Ratnagiri Kilminnal"],["Sanjay Gandhi Postgraduate Institute of Medical Sciences","Prasad, Narayan","印度","Uttar Pradesh","Lucknow"],["Trivandrum Medical College Hospital","Krishnan, Ragi","印度","Kerala","Thiruvananthapuram"],["Government Medical College, Kozhikode","Gopinath, Biju","印度","Kerala","Kozhikode"],["M.S. Ramaiah Medical College and Hospital","Eswarappa, Mahesh","印度","Karnataka","Bangalore"],["Postgraduate Institute of Medical Education & Research (PGIMER)","Ramachandran, Raja","印度","Chandigarh","Chandigarh"],["King George Medical University (KGMU)","Gautam, Medhavi","印度","Uttar Pradesh","Lucknow"],["Norzel Medical and Diagnostic Clinic - Cebu City","De Asis, Norman Cornelio","菲律宾","Cebu","Cebu"],["St. Luke's Medical Center - Quezon City","Crisostomo, Arlene","菲律宾","Quezon City","Quezon City"],["The Medical City-Ortigas Ave","Valdenor, Czarlota","菲律宾","Pasig City","Pasig City"],["National Kidney and Transplant Institute","Villanueva, Anthony","菲律宾","Quezon City","Quezon City"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["北京大学第一医院生物医学研究伦理委员会","同意","2025-07-23"]]

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: 68 ； 国际: 454 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 3 ；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 3 ；

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：2025-03-28；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2025-06-05；
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；