广州NAII期临床试验-一项检测vicadrostat联合恩格列净是否对慢性肾脏疾病患者有帮助的研究

登记号	CTR20253076	试验状态	进行中
申请人联系人	勃林格殷格翰临床试验信息公示组	首次公示信息日期	2025-08-05
申请人名称	Boehringer Ingelheim International GmbH/ 勃林格殷格翰(中国)投资有限公司/ Boehringer Ingelheim Pharma GmbH & Co. KG/ Almac Clinical Services Limited；Boehringer Ingelheim Pharma GmbH & Co. KG

登记号	CTR20253076
相关登记号	暂无
药物名称	NA
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	慢性肾脏疾病
试验专业题目	一项在存在肾脏疾病进展风险的慢性肾脏疾病受试者中研究vicadrostat和恩格列净同时启动与交错启动给药安全性和有效性的II期、随机、双盲、平行分组、多中心、国际试验
试验通俗题目	一项检测vicadrostat联合恩格列净是否对慢性肾脏疾病患者有帮助的研究
试验方案编号	1378-0023	方案最新版本号	2.0
版本日期:	2025-03-24	方案是否为联合用药	否

申请人名称	[["Boehringer Ingelheim International GmbH"],["勃林格殷格翰(中国)投资有限公司"],["Boehringer Ingelheim Pharma GmbH & Co. KG"],["Almac Clinical Services Limited；Boehringer Ingelheim Pharma GmbH & Co. KG"]]
联系人姓名	勃林格殷格翰临床试验信息公示组	联系人座机	021-52883966	联系人手机号
联系人Email	MEDCTIDgroup.CN@boehringer-ingelheim.com	联系人邮政地址	上海市-上海市-静安区南京西路1601号越洋广场29楼	联系人邮编	200040

1. 本试验主要目的是比较交错启动与同时启动vicadrostat联合恩格列净治疗时eGFR从基线至第14周的绝对变化。 2. 次要目的还是为了比较交错启动与同时启动vicadrostat联合恩格列净治疗时eGFR、SBP和血清钾水平从基线至第12周的绝对变化以及UACR从基线至第6周的相对变化。

试验分类	安全性和有效性	试验分期	II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	[["至少18岁且至少达到所在国家的法定知情同意年龄（大于18岁）。"],["入选本试验前，根据ICH-GCP和当地法规签署书面知情同意书并注明日期。"],["男性或女性受试者。WOCBP（见第4.2.2.3节）和有生育能力的男性必须按照ICH M3（R2）的规定准备并且能够使用高效避孕方法，即坚持正确使用情况下年失败率低于1%的避孕方法。符合这些标准的避孕方法列表和使用持续时间说明参见受试者须知。"],["基于近期（即1年内）和访视1时记录的两次eGFR测量值（每次eGFR≥20且<60 mL/min/1.73m2，不考虑UACR），作为CKD进展风险的证据。第一次将根据当地实验室的历史结果进行评估，第二次将根据中心实验室在访视1时分析的血清肌酐确定。"],["于访视1前≥4周，接受了临床上适当、稳定剂量的ACEi或ARB治疗（但两者并未联用），且试验持续期间并无计划改变治疗方案。"]]
排除标准	[["访视2前4周内接受过SGLT2i治疗。不应为了入组试验而中断SGLT2i治疗。"],["根据研究者的判断，在访视1前14天内接受了MRA、ASi或保钾利尿剂治疗，或在随机化前需要接受这类治疗，或计划在试验期间接受这类治疗。不应为了入组试验而中断MRA或ASi治疗。"],["访视1时血钾>5.2 mmol/L"],["访视1时血ALT或AST>3×ULN"],["已知重度肝功能损害（即Child Pugh C级肝硬化）"],["接受透析、功能性肾脏移植或计划接受移植"],["在过去60天内接受新的免疫抑制疗法治疗新的肾脏疾病（或既存肾脏疾病复发/发作）"],["目前正在接受全身性盐皮质激素替代治疗（例如氟氢可的松）"]]

试验药	[["中文通用名:NA 英文通用名:Vicadrostat(BI690517) 商品名称:NA","剂型:片剂 规格:薄膜包衣片10mg/粒 用法用量:1片，QD 用药时程:6周或12周（按随机分组）"],["中文通用名:恩格列净 英文通用名:Empagliflozin(BI10773) 商品名称:Jardiance（欧唐静）","剂型:片剂 规格:10mg 用法用量:1片QD 用药时程:12周"]] 序号 名称 用法
对照药	[["中文通用名:安慰剂（对应Vicadrostat(BI690517) 英文通用名:PlaceboforVicadrostat(BI690517) 商品名称:NA","剂型:片剂 规格:不适用 用法用量:1片QD 用药时程:6周或12周（按随机分组）"]] 序号 名称 用法

主要终点指标及评价时间	[["主要终点是eGFR（mL/min/1.73m2）从基线至第14周的绝对变化。","从基线至第14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（mL/min/1.73 m2）从基线至第12周的绝对变化","从基线至第12周","有效性指标+安全性指标"],["SBP（mmHg）从基线至第12周的绝对变化","从基线至第12周","安全性指标"],["UACR从基线至第6周的相对变化（比值）","从基线至第6周","安全性指标"],["血清钾（mmol/L）从基线至第12周的绝对变化","从基线至第12周","有效性指标+安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	侯凡凡	学位	医学博士	职称	主任医师
	电话	020-61641591	Email	ffhouguangzhou@163.com	邮政地址	广东省-广州市-广州大道北1838号
	邮编	510515	单位名称	南方医科大学南方医院

[["南方医科大学南方医院","侯凡凡","中国","广东省","广州市"],["南昌大学第一附属医院","陈钦开","中国","江西省","南昌市"],["北京清华长庚医院","李月红","中国","北京市","北京市"],["南宁市第一人民医院","廖兵","中国","广西壮族自治区","南宁市"],["浙江省人民医院","李一文","中国","浙江省","杭州市"],["宁夏医科大学总医院","田娜","中国","宁夏回族自治区","银川市"],["济南市中心医院","王小平","中国","山东省","济南市"],["西安交通大学第一附属医院","路万虹","中国","陕西省","西安市"],["安徽医科大学第二附属医院","王德光","中国","安徽省","合肥市"],["四川大学华西医院","胡章学","中国","四川省","成都市"],["宜宾市第二人民医院","解德琼","中国","四川省","成都市"],["深圳市第二人民医院","万启军","中国","广东省","深圳市"],["汕头大学医学院第二附属医院","周添标","中国","广东省","汕头市"],["宁波市第二医院","罗群","中国","浙江省","宁波市"],["南京医科大学第二附属医院","戴春笋","中国","江苏省","南京市"],["CEMEDIC - Centro de Especialidades Medicas","Claudio Majul","阿根廷","Ciudad Autónoma de BuenosAires","Villa Luro"],["CEDIC - Centro de Investigacion Clinica","Gabriela Sturla","阿根廷","Ciudad Autónoma de BuenosAires","CABA"],["Instituto Medico Catamarca - IMEC","Natacha Maldonado","阿根廷","Santa Fe","Rosario"],["Mautalen- Salud e Investigacion","Silvina Grimoldi","阿根廷","Ciudad Autónoma de BuenosAires","CABA"],["IDIM - Instituto de Diagnostico e Investigaciones Metabolicas","Santiago Oscar Bruzone","阿根廷","Ciudad Autonoma de Buenos Aires","Ciudad Autonoma de Buenos Aires"],["Sanatorio Güemes","Javier Farias","阿根廷","Buenos Aires","Capital Federal"],["Westmead Hospital","Vincent Lee","澳大利亚","New South Wales","Westmead"],["Royal Perth Hospital","Markus Schlaich","澳大利亚","Western Australia","Perth"],["Austin Health","Elif Ekinci","澳大利亚","Victoria","Heidelberg"],["Northern Hospital Epping","Timothy Pianta","澳大利亚","Victoria","Epping"],["John Hunter Hospital","Bobby Chacko","澳大利亚","New South Wales","New Lambton Heights"],["ULB Hopital Erasme","Caroline La","比利时","Bruxelles","Bruxelles"],["UZ Leuven","Amaryllis Van Craenenbroeck","比利时","Vlaams-Brabant","Leuven"],["Brussels - UNIV Saint-Luc","Nathalie Demoulin","比利时","Bruxelles","Bruxelles"],["Humani - CHU Charleroi - Chimay","Nathan Neveux","比利时","Hainaut","Lodelinsart"],["CEPIC - Centro Paulista de Investigacao Clinica","Breno Alves","巴西","Estado de Sao Paulo","Sao Paulo"],["Chronos Pesquisa Clinica","Maria Polcheira","巴西","Distrito Federal","Brasilia"],["Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto","Ana Carolina Tome","巴西","Estado de Sao Paulo","Sao Jose do Rio Preto"],["Cpquali Pesquisa Clinica Ltda","Gustavo Akerman Augusto","巴西","Migration Data","Sao Paulo"],["Centro de Pesquisa do Hospital Evangelico de Belo Horizonte","Tiago Cerqueira","巴西","Minas Gerais","Belo Horizonte"],["Fundacao Oswaldo Ramos (Hospital do Rim)","Maria Canziani","巴西","Sao Paulo","Sao Paulo"],["Galileo Medical Research Ltda","Helady Pinheiro","巴西","Minas Gerais","Juiz de Fora"],["Centro de Pesquisa Clinica de Nefrologia do ICHC","Irene Noronha","巴西","Sao Paulo","Sao Paulo"],["Toronto General Hospital","David Cherney","加拿大","Ontario","Toronto"],["Sunnybrook Health Sciences Centre","Ayodele Odutayo","加拿大","Ontario","Toronto"],["Diex Recherche (Trois-Rivieres)","Jean-Francois Naud","加拿大","Quebec","Trois-Rivieres"],["CARe Clinic (Red Deer)","Josias Badenhorst","加拿大","Alberta","Red Deer"],["Bluewater Clinical Research","Sean Peterson","加拿大","Ontario","Sarnia"],["Heart Health Institute (Scarborough)","Andrew Yadegari","加拿大","Ontario","Scarborough"],["Hospital Slany, Internal Department","Matej Falc","捷克","NA","Slany"],["MILAN KVAPIL s.r.o.","Dagmar Bartaskova","捷克","Czechia","Pribram"],["DIKa centrum s.r.o.","Marian Pirchala","捷克","NA","Havirov"],["Medizinische Hochschule Hannover","Jessica Kaufeld","德国","NA","Hannover"],["DaVita Clinical Research Germany GmbH Geilenkirchen","Thilo Kruger","德国","NA","Geilenkirchen"],["Klinikum Bielefeld","Joachim Feldkamp","德国","NRW","Bielefeld"],["Zentrum Fur Nieren Hochdruck und Stoffwechselerkrankungen","Georg Schlieper","德国","Niedersachsen","Hannover"],["Internistische Gemeinschaftspraxis in Bunde","Kai Konemann","德国","NRW","Bunde"],["DKD Helios Klinik Wiesbaden","Frank Strutz","德国","Hessen","Wiesbaden"],["Universitatsklinikum Frankfurt","Jeannine Lang","德国","Hessen","Frankfurt"],["Robert Bosch Gesellschaft für medizinische Forschung mbH","Jorg Latus","德国","NA","Stuttgart"],["Universitatsklinikum Carl Gustav Carus Dresden","Christian Hugo","德国","Sachsen","Dresden"],["Nephrologische Gemeinschaftspraxis, Hamann/Bacinovic/Jacobsen","Mustafa Bacinovic","德国","Niedersachsen","Rotenburg"],["Centro de Salud Milladoiro","Sergio Cinza Sanjurjo","西班牙","Galicia","A Coruna"],["Centro de Salud Naranco","Ana Maria Piera Carbonell","西班牙","Asturias","Oviedo"],["Eap Osona Sud Alt Congost S.L.P. Cap Centelles","Silvia Narejos Perez","西班牙","Catalunya","Centelles, Barcelona"],["C.A.P. Sardenya","Carlos Brotons Cuixart","西班牙","Catalunya","Barcelona"],["Centro de Salud de San Juan","Emiliano Rodriguez Sanchez","西班牙","Salamanca","Salamanca"],["Centro de Salud Cartagena Casco Antiguo","Ana Cebrian Cuenca","西班牙","Murcia","Cartagena"],["HOP Hotel-Dieu","Jacques Dantal","法国","Pays de la Loire","Nantes"],["HOP Bicetre","Renaud Snanoudj","法国","Ile-de-France","Le Kremlin-Bicetre"],["HOP Civil","Nans Florens","法国","NA","Strasbourg"],["Queen Elizabeth University Hospital","Sokratis Stoumpos","大不列颠及北爱尔兰","NA","Glasgow"],["Sunderland Royal Hospital","Saeed Ahmed","大不列颠及北爱尔兰","Tyne and Wear","Sunderland"],["Belmont Health Centre","Jaimini Tanna","大不列颠及北爱尔兰","NA","Harrow"],["Richford Gate Medical Practice","David Wingfield","大不列颠及北爱尔兰","NA","London"],["Velocity Clinical Research, High Wycombe","Judith Mackay","大不列颠及北爱尔兰","Buckinghamshire","High Wycombe"],["University Hospital Monklands","Alastair Rankin","大不列颠及北爱尔兰","NA","Airdrie"],["Royal Berkshire Hospital","Oliver Flossmann","大不列颠及北爱尔兰","NA","Reading"],["Banbury Cross Health Centre","James Kennard","大不列颠及北爱尔兰","Oxfordshire","Banbury"],["Fondazione Policlinico Universitario A. Gemelli IRCCS","Giuseppe Grandaliano","意大利","Lazio","Roma"],["Universita degli Studi di Perugia","Gianpaolo Reboldi","意大利","Umbria","Perugia"],["Ospedale SS Annunziata","Mario Bonomini","意大利","Abruzzo","Chieti"],["Istituto di Ricerche Farmacologiche Mario Negri IRCCS","Aneliya Parvanova","意大利","Lombardia","Ranica (BG)"],["Tokyo Medical University Hachioji Medical Center","Takashi Oda","日本","NA","Tokyo, Hachioji"],["Omihachiman Community Medical Center","Tomoharu Ida","日本","NA","Shiga, Omihachiman"],["Saiseikai Yokohamashi Nanbu Hospital","Tamio Iwamoto","日本","NA","Kanagawa, Yokohama"],["Tsuchiura Kyodo General Hospital","Takayuki Toda","日本","NA","Ibaraki, Tsuchiura"],["Ageo Central General Hospital","Kenichiro Kojima","日本","NA","Saitama, Ageo"],["Kasugai Municipal Hospital","Yosuke Saka","日本","NA","Aichi, Kasugai"],["Osaka General Medical Center","Terumasa Hayashi","日本","NA","Osaka, Osaka"],["National Hospital Organization Chibahigashi National Hospital","Takehiko Kawaguchi","日本","NA","Chiba, Chiba"],["Seoul National University Bundang Hospital","Sejoong Kim","大韩民国","NA","Seongnam"],["Hanyang University Medical Center","Chang Hwa Lee","大韩民国","NA","Seoul"],["The Catholic University of Korea, Eunpyeong St. Mary's Hospital","Tae Hyun Ban","大韩民国","NA","Seoul"],["Yonsei University Wonju Severance Christian Hospital","Byoung-Geun Han","大韩民国","NA","Wonju-si, Gangwon State"],["Korea University Ansan Hospital","Ji Hee Yu","大韩民国","Gyeonggi-do","Ansan-si"],["Centenario Hospital Miguel Hidalgo","Alfredo Chew Wong","墨西哥","NA","NA"],["Unidad de Investigacion Clinica y Atencion Medica HEPA SC","Marisol Herrera Marmolejo","墨西哥","NA","NA"],["Sociedad de Metabolismo y Corazon S.C.","Rosa Isela Luna Ceballos","墨西哥","NA","NA"],["SOLTMED SMO","Marcos Garcia Nava","墨西哥","NA","NA"],["CLINICA OMEGA DIABETES","Jose Sanchez Mijangos","墨西哥","NA","NA"],["Medical Care & Research SA de CV","Omar Enrique Orea Rodríguez","墨西哥","NA","NA"],["Tuanku Fauziah Hospital","Noorhafini Abdul Sukur","马来西亚","Perlis","Kangar"],["Hospital Canselor Tuanku Muhriz","Rozita Mohd","马来西亚","Kuala Lumpur","Cheras"],["Hospital Sultan Idris Shah Serdang","Bak Leong Goh","马来西亚","Selangor","Kajang"],["Hospital Kuala Lumpur","Tan Min Hui","马来西亚","NA","Kuala Lumpur"],["Bethesda Diabetes Research Center, Hoogeveen","Adriaan Kooy","荷兰（王国）","Drenthe","Hoogeveen"],["Catharina Ziekenhuis","Stijn Konings","荷兰（王国）","Noord-Brabant","Eindhoven"],["Amsterdam UMC Locatie AMC","Liffert Vogt","荷兰（王国）","Noord-Holland","Amsterdam"],["Albert SchweitzerZiekenhuis","Jeroen Van Der Net","荷兰（王国）","Zuid-Holland","Dordrecht"],["Dunedin Hospital","Rob Walker","新西兰","NA","Dunedin"],["Momentum Clinical Research - Kapiti Coast","Andrew Edwards","新西兰","Wellington Region","Kapiti"],["Waikato Hospital","Kannaiyan Rabindranath","新西兰","NA","Hamilton"],["Norzel Medical and Diagnostic Clinic","Norman De Asis","菲律宾","NA","Cebu City"],["Institute for Studies on Diabetes Foundation Inc.","Elizabeth Ann Catindig","菲律宾","Metro Manila","Marikina City"],["Philippine Heart Center","Clodoialdo Caringal","菲律宾","NA","Quezon City"],["Institute for Studies on Diabetes Foundation Inc.","Araceli Panelo","菲律宾","Metro Manila","Marikina City"],["Senor Santo Nino Hospital","Ronaldo Toledo","菲律宾","Tarlac","Camiling"],["Pro Familia Altera Sp. z o.o.","Danuta Wronska","波兰","Slaskie","Katowice"],["American Heart Of Poland Sp. Z O.O.","Aleksander Zurakowski","波兰","Malopolskie","Chrzanow"],["Pro Salus Sp. z o.o. sp.k.","Marcin Ojrzanowski","波兰","Lodz","Lodz"],["CENTRUM MEDYCZNE","Grzegorz Grzesk","波兰","Bydgoszcz","Bydgoszcz"],["Siriraj Hospital","Nuttasith Larpparisuth","泰国","NA","Bangkok"],["King Chulalongkorn Memorial Hospital","Paweena Susantitaphong","泰国","NA","Thailand"],["Phramongkutklao Hospital","Bancha Satirapoj","泰国","NA","BANGKOK"],["Maharaj Nakom Chiangmai Hospital","Kajohnsak Noppakun","泰国","NA","Chiang Mai"],["National Taiwan University Hospital","Tai-Shuan Lai","中国台湾","NA","Taipei"],["Taichung Veterans General Hospital","Tung-Min Yu","中国台湾","NA","Taichung"],["Kaohsiung Medical University Chung-Ho Memorial Hospital","Yi-Wen Chiu","中国台湾","NA","Kaohsiung"],["Mackay Memorial Hospital","Cheng-Jui Lin","中国台湾","NA","Taipei"],["Clinical Research of Brandon LLC","German Alvarez","美利坚合众国","Florida","Brandon"],["Endocrine Associates","Gerardo Bueso","美利坚合众国","Texas","Houston"],["Research by Design, LLC","April Kennedy","美利坚合众国","Illinois","Chicago"],["Encore Medical Research","Rodolfo Perez","美利坚合众国","Florida","Hollywood"],["Nephrology Associates of Northern Illinois and Indiana - Oak Brook","Sadaf Elahi","美利坚合众国","Illinois","Hinsdale"],["Kansas Nephrology Research Institute, LLC","Dennis Ross","美利坚合众国","Kansas","Wichita"],["Tidewater Physicians Multispecialty Group","Linda Schneider","美利坚合众国","Virginia","Newport News"],["Valiance Clinical Research-Tarzana-68237","Kalpesh Patel","美利坚合众国","California","Tarzana"],["Clinical Advancement Center, PLLC","Pablo Pergola","美利坚合众国","Texas","San Antonio"],["Brookview Hills Research Associates LLC","Gregory Greenwood","美利坚合众国","North Carolina","Winston-Salem"],["Lucas Research, Inc.","Kathryn Jean Lucas","美利坚合众国","North Carolina","Morehead City"],["San Marcus Research Clinic, Inc.","Idalia Acosta","美利坚合众国","Florida","Miami Lakes"],["Florida Kidney Physicians - Riverview/Brandon","Amit Johnsingh","美利坚合众国","Florida","Riverview"],["Arlington Nephrology","Bhasker Mehta","美利坚合众国","Texas","Arlington"],["Northwest Louisiana Nephrology","Marwan Kaskas","美利坚合众国","Louisiana","Shreveport"],["Total Research Group, LLC","Juan Fernandez","美利坚合众国","Florida","Miami"],["Utah Kidney Research Institute","Sanjiv Anand","美利坚合众国","Utah","Salt Lake City"],["Heritage Valley Medical Group","Timothy JACKSON","美利坚合众国","Pennsylvania","Beaver"],["North America Research Institute","Aamir Jamal","美利坚合众国","California","San Dimas"],["West Orange Endocrinology","Jose Mandry","美利坚合众国","Florida","Ocoee"],["AA MRC LLC","Ahmed Arif","美利坚合众国","Michigan","Flint"],["LSU Health Sciences Center","Rajesh Mohandas","美利坚合众国","Louisiana","New Orleans"],["Finlay Medical Research Corp","Lilia Rodriguez Ables","美利坚合众国","Florida","Miami"],["Boise Kidney and Hypertension, PLLC","Arnold Silva","美利坚合众国","Idaho","Boise"],["Clinical Research Consultants, LLC","Ahmed Awad","美利坚合众国","NA","NA"],["Amicis Research Center - Valencia","Billy Hour","美利坚合众国","California","Valencia"],["Seacoast Kidney and Hypertension Specialists","Sucharit Joshi","美利坚合众国","New Hampshire","Portsmouth"],["Southeast Renal Research Institute","Claude Galphin","美利坚合众国","Tennessee","Chattanooga"],["Nephrology Consultants, LLC","John Clark","美利坚合众国","Alabama","Huntsville"],["Focus Clinical Research","Hessam Aazami","美利坚合众国","California","West Hills"],["Healor Primary Care","Raj Singh","美利坚合众国","NA","NA"],["FDI Clinical Research – Mayagüez","William Hurtado-Santiago","美利坚合众国","Puerto Rico","Mayaguez"],["Durham Nephrology Associates","Amarnath Kathresal","美利坚合众国","North Carolina","Durham"],["Javara Inc.-Stephenville-68996","Benjamin Marcum","美利坚合众国","Texas","Stephenville"],["Michigan Kidney Consultants","Fahd Al-Saghir","美利坚合众国","Michigan","Pontiac"],["Midwest Nephrology Associates","Gary Singer","美利坚合众国","Missouri","St. Peters"],["Orange County Clinical Trials","Steve Sitar","美利坚合众国","California","Anaheim"],["Velocity Clinical Research, Savannah","Paul Bradley","美利坚合众国","Georgia","Savannah"],["Masters of Clinical Research, Inc","Amy Sprague","美利坚合众国","Georgia","Augusta"],["Hillcrest Medical Research","John Hill","美利坚合众国","Florida","DeLand"],["Endocrine Associates of Long Island","Michael Shanik","美利坚合众国","New York","Smithtown"],["Western Nephrology, Arvada","Joseph Abdallah","美利坚合众国","Colorado","Arvada"],["Sky Clinical Research","Demetri Marshall","美利坚合众国","Mississippi","Fayette"],["Nephrology Associates of Northern Illinois and Indiana - Fort Wayne","Andrew O'Shaughnessy","美利坚合众国","Indiana","Fort Wayne"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["南方医科大学南方医院医学伦理委员会","修改后同意","2025-07-11"],["南方医科大学南方医院医学伦理委员会","同意","2025-07-24"]]

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: 42 ； 国际: 416 ；
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：2025-07-18；
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；