杭州TAK-279胶囊II期临床试验-一项在中重度活动性溃疡性结肠炎受试者中评价TAK-279口服给药的疗效和安全性的II期研究

登记号	CTR20253088	试验状态	进行中
申请人联系人	陈曦	首次公示信息日期	2025-08-06
申请人名称	Takeda Development Center Americas, Inc./ 武田（中国）国际贸易有限公司/ Serán BioScience, LLC/ Almac Clinical Services LLC

登记号	CTR20253088
相关登记号	暂无
药物名称	TAK-279胶囊
药物类型	化学药物
临床申请受理号	JXHL2500018
适应症	中重度活动性溃疡性结肠炎
试验专业题目	一项在中重度活动性溃疡性结肠炎受试者中评价TAK-279口服给药的疗效和安全性的II期、多中心、随机、安慰剂对照、双盲诱导治疗研究
试验通俗题目	一项在中重度活动性溃疡性结肠炎受试者中评价TAK-279口服给药的疗效和安全性的II期研究
试验方案编号	TAK-279-UC-2001	方案最新版本号	修正案2
版本日期:	2024-08-30	方案是否为联合用药	否

申请人名称	[["Takeda Development Center Americas, Inc."],["武田（中国）国际贸易有限公司"],["Serán BioScience, LLC"],["Almac Clinical Services LLC"]]
联系人姓名	陈曦	联系人座机	021-68279888	联系人手机号	13564525055
联系人Email	xi.chen3@takeda.com	联系人邮政地址	上海市-上海市-浦东新区海阳西路555号前滩中心35楼	联系人邮编	200126

主要目的：评价TAK-279 50 mg和75 mg QD口服给药对比安慰剂在中重度活动性溃疡性结肠炎（UC）受试者中的疗效，即第12周时达到临床缓解。 次要目的：评价TAK-279 50 mg和75 mg QD口服给药对比安慰剂在中重度活动性UC受试者中的疗效，即第12周时达到临床应答、症状缓解和内镜变化；评价TAK-279在中重度活动性UC受试者中对于患者报告的UC症状的影响；评价TAK-279在中重度活动性UC受试者中对于疾病特定健康相关生活质量（HRQoL）的影响。 安全性目的：评价TAK-279 50 mg和75 mg QD口服给药对比安慰剂在中重度活动性UC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	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 75岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	[["研究者认为，受试者愿意并且能够理解并完全遵守研究程序和要求。n在开始任何研究程序之前，受试者已提供知情同意书（即以书面形式，通过签署并注明日期的ICF记录）和任何要求的隐私授权。"],["签署ICF时，受试者的年龄必须≥18岁且≤75岁。对于65岁或以上的受试者，将由研究者进行总体获益-风险评估，以通过知情同意程序确保受试者的安全。韩国成年受试者的年龄要求为≥19岁。"],["受试者在筛选时必须患有中重度活动性UC，定义如下：na.t改良Mayo评分为5-9分，和nb.t内镜检查分项评分≥2。"],["受试者必须在筛选前至少30天确诊UC（内镜检查和组织学），且疾病范围从肛缘延伸＞15 cm。诊断记录定义为：na.t用于确认组织学诊断的活检报告，和nb.t基于既往结肠镜检查记录病程的报告。"],["根据医生评估（根据下面的[a]或[b]或两者的组合），受试者对一种或多种UC治疗应答不足、失去应答或不耐受：na.t6-巯基嘌呤或硫唑嘌呤，口服或静脉注射皮质类固醇，或有皮质类固醇依赖史，（无法成功减少皮质类固醇而不出现UC症状），口服5-ASA。n和/或nb.t生物制剂（如TNF拮抗剂、IL-23p 19抗体、IL-12/23p40抗体、维得利珠单抗）或任何强化治疗（如α4整合素拮抗剂、JAKi或S1P受体调节剂）。"],["受试者未妊娠、未哺乳或无生育能力。对于具有生殖能力的个体，如果性生活活跃，需同意在研究期间和研究药物末次给药后10天内遵守避孕要求。必须满足以下避孕要求：na.t从签署知情同意书开始，在整个研究期间以及研究药物末次给药后10天内，男性（按出生时性别）受试者需要采取有效的避孕措施（男用避孕套）。nb.t手术绝育的女性（按出生时性别）受试者；或确认绝经后状态的无生育能力的女性受试者（即促卵泡激素水平＞40 mIU/mL）；或如果与能产生精子的未绝育个体有性生活，女性受试者同意从签署知情同意书开始，在整个研究期间和末次给药后10天内使用高效避孕方法。"]]
排除标准	[["患有不确定/未分类的炎症性肠病、显微镜下结肠炎、缺血性结肠炎、感染性结肠炎、放射性结肠炎、结肠炎相关憩室性疾病和/或提示克罗恩病（CD）的临床/组织学结果的受试者。"],["患有UC并发症（如缩窄、狭窄、瘘、短肠综合征或研究期间可能需要手术的任何其他表现）的受试者可能会妨碍使用改良Mayo评分来评估治疗应答，或可能混淆TAK-279治疗获益的评价。"],["当前或既往患有脓肿的受试者，除非在随机化前至少6周进行引流和治疗，并且预期在治疗期间不需要手术。"],["既往接受过大型UC手术，包括结肠次全切除术或直肠结肠切除术，或者计划在研究期间接受肠道手术的受试者。对于局部UC手术（例如，节段性结肠切除术）的受试者，只要不影响疗效评估，则允许参加研究。"],["在筛选前6个月内接受过任何类型的小肠或结肠手术，或在筛选前3个月内接受过任何其他腹内手术的受试者。排除＞2次肠道切除术的受试者。"],["当前接受过回肠造口术或结肠造口术的受试者。使用J型贮袋的受试者被排除在外，因为J型贮袋可能导致造口。"],["3类或以上强化治疗（包括生物制剂、JAK抑制剂、α4整合素拮抗剂或S1P受体调节剂类别）失败的受试者。"]]

试验药	[["中文通用名:TAK-279胶囊 英文通用名:TAK-279Tablet 商品名称:NA","剂型:胶囊 规格:25mg 用法用量:每次口服TAK-27950mgQD（25mg×2粒胶囊和安慰剂×1粒胶囊）、TAK-27975mgQD（25mg×3粒胶囊）或匹配的安慰剂胶囊QD（安慰剂×3粒胶囊） 用药时程:12个月"]] 序号 名称 用法
对照药	[["中文通用名:安慰剂 英文通用名:placebo 商品名称:NA","剂型:胶囊 规格:NA 用法用量:每次口服TAK-27950mgQD（25mg×2粒胶囊和安慰剂×1粒胶囊）、TAK-27975mgQD（25mg×3粒胶囊）或匹配的安慰剂胶囊QD（安慰剂×3粒胶囊） 用药时程:12个月"]] 序号 名称 用法

主要终点指标及评价时间	[["评价TAK-279 50 mg和75 mg QD口服给药相较于安慰剂在中重度活动性UC受试者中于第12周时达到临床缓解的疗效。","第12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	[["评价TAK-279 50 mg和75 mg QD口服给药相较于安慰剂在中重度活动性UC受试者中于第12周时达到临床应答、症状缓解和内镜变化的疗效。","第12周","有效性指标"],["在中重度活动性UC受试者中评价TAK-279对患者报告的UC症状的影响。","第12周","有效性指标"],["评价TAK-279对中重度活动性UC受试者的疾病特异性健康相关生活质量（HRQoL）的影响。","第12周","有效性指标"],["在中重度活动性UC受试者中，评估TAK-279 50 mg和75 mg QD口服给药与安慰剂相比的安全性和耐受性。","试验期间","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	曹倩	学位	博士	职称	主任医师
	电话	13588706896	Email	caoq@srrsh.com	邮政地址	浙江省-杭州市-钱塘区下沙路 368 号
	邮编	310016	单位名称	浙江大学医学院附属邵逸夫医院

[["浙江大学医学院附属邵逸夫医院","曹倩","中国","浙江省","杭州市"],["重庆市人民医院（重庆中俄友好医院）","郭红","中国","重庆市","重庆市"],["常州市第二人民医院","刘文佳","中国","江苏省","常州市"],["上海市浦东新区周浦医院","冉志华","中国","上海市","上海市"],["中国医科大学附属盛京医院滑翔院区","郑长清","中国","辽宁省","沈阳市"],["上海交通大学医学院附属仁济医院","沈俊","中国","上海市","上海市"],["中南大学湘雅二医院","王学红","中国","湖南省","长沙市"],["四川大学华西医院","张虎","中国","四川省","成都市"],["武汉大学人民医院","安萍","中国","湖北省","武汉市"],["中山大学附属第六医院 (广东省胃肠肛门医院)","高翔","中国","广东省","广州市"],["Hightower Clinical - SSM Health","Ali, Tauseef","美国","Oklahoma City","Oklahoma City"],["Auzmer Research","Ausaf, Niaz","美国","Lakeland","Lakeland"],["Gastroenterology Associates, PA","Barnes, Matthew","美国","Greenville","Greenville"],["DiGiovanna Institute for Medical Education and Research","DiGiovanna, Michael, J","美国","North Massapequa","North Massapequa"],["Victorium Clinical Research","Doshi, Ankur, A","美国","Houston","Houston"],["University Of Louisville","Dryden, Gerald, W","美国","Louisville","Louisville"],["Tyler Research Institute, LLC","Duvall, George, A","美国","Tyler","Tyler"],["United Medical Doctors","Hong, John","美国","Murrieta","Murrieta"],["Emory University Hospital, The Emory Clinic","Iskandar, Heba","美国","Atlanta","Atlanta"],["GastroIntestinal BioSciences","Karyotakis, Nicholas, C","美国","Los Angeles","Los Angeles"],["University of Washington Medical Center - Montlake","Lee, Scott, D","美国","Seattle","Seattle"],["University Gastroenterology","Mueller, Lisa, A","美国","Providence","Providence"],["Woodholme Gastroenterology Associates","Onwueme, Kenolisa, C","美国","Glen Burnie","Glen Burnie"],["GI PROS, Inc.","Phillips, Raymond, W","美国","Naples","Naples"],["Atlanta Center For Gastroenterology, P.C.","Rausher, David, B","美国","Decatur","Decatur"],["USF Health Morsani Center for Advanced Healthcare","Rosario, Michelle, S","美国","Tampa","Tampa"],["Novel Research, LLC","Sana, Moazzam","美国","Bellaire","Bellaire"],["Las Vegas Medical Research","Stone, Christian, D","美国","Las Vegas","Las Vegas"],["West Central Gastroenterology, LLP, d/b/a/ Gastro Florida","Weiss, Lawrence Michael","美国","Clearwater","Clearwater"],["Mater Cancer Care Centre-Mater Health Services","Begun, Jakob","澳大利亚","South Brisbane","South Brisbane"],["The Queen Elizabeth Hospital","Bryant, Robert, V","澳大利亚","Woodville","Woodville"],["Western Health/Footscray Hospital","Kronborg, Ian","澳大利亚","Melbourne","Melbourne"],["Concord Repatriation General Hospital","Leong, Rupert, W","澳大利亚","Concord","Concord"],["Northern Hospital Epping","Mayur Garg","澳大利亚","Epping","Epping"],["Flinder Medical Centre","Mountifield, Reme, E","澳大利亚","Bedford Park","Bedford Park"],["Sir Charles Gairdner Hospital Lung Institute Of Western Australia","Siddique, Nabil","澳大利亚","Nedlands","Nedlands"],["The Alfred Hospital","Sparrow, Miles, P","澳大利亚","Melbourne","Melbourne"],["Harry Perkins Medical Research Institute Fiona Stanley Hospital","Thin, Lena, W","澳大利亚","Murdoch","Murdoch"],["Royal Perth Hospital","Venugopal, Kannan","澳大利亚","Perth","Perth"],["Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel","Franchimont, Denis","比利时","Brussel","Brussel"],["Universitair Ziekenhuis Leuven","Guedelha Sabino, Joao Pedro","比利时","Leuven","Leuven"],["Pecs University Clinical Centrer Mohacs Hospital","Draganova, Raina, R","保加利亚","Sofia","Sofia"],["Acibadem City clinic Tokuda hospital","Karagyozov, Petko","保加利亚","Sofia","Sofia"],["University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)","Penchev, Plamen, I","保加利亚","Sofia","Sofia"],["University Hospital City Clinic Cancer Center","Petrov, Asen","保加利亚","Sofia","Sofia"],["UMBAL Kaspela","Stanchev, Desislav","保加利亚","Plovdiv","Plovdiv"],["Diagnostic-Consultative Center Aleksandrovska EOOD","Stefanova-Petrova, Diana, V","保加利亚","Sofia","Sofia"],["Centre Hospitalier de l'Universite de Montreal","Battat, Robert","加拿大","Montreal","Montreal"],["The Research Institute of the McGill University Health Center","Bessissow, Talat","加拿大","Montreal","Montreal"],["London Health Sciences Centre - University Hospital","Jairath, Vipul","加拿大","London","London"],["Heritage Medical Research Clinic - University Of Calgary","Ma, Christopher","加拿大","Calgary","Calgary"],["London Health Sciences Centre - Victoria Hospital","Ponich, Terry, P","加拿大","London","London"],["Fraser Clinical Trials","Wan Lam, Mindy Ching","加拿大","New Westminster","New Westminster"],["Endohope Clinic","Bajer, Lukas","捷克","Prague 5","Prague 5"],["University Hospital Brno","Konecny, Stefan","捷克","Brno","Brno"],["EndoArt","Koskova, Radka","捷克","Ostrava","Ostrava"],["Gastromedic s.r.o","Leksa, Vaclav","捷克","Pardubice","Pardubice"],["Axon Clinical s.r.o.","Matous, Jan","捷克","Prague 5","Prague 5"],["NH Hospital","Serclova, Zuzana","捷克","Horivice","Horivice"],["Masaryk Hospital","Stehlik, Jiri","捷克","Ustecky","Ustecky"],["Vojenska Nemocnice Brno","Stepek, David","捷克","Brno","Brno"],["Fakultni Nemocnice Ostrava","Svoboda, Pavel","捷克","Ostrava-Poruba","Ostrava-Poruba"],["SurGal Clinic SRO","Ulbrych, Jan","捷克","Brno","Brno"],["Hepato-Gastroenterologie HK, s.r.o.","Vanasek, Tomas","捷克","Hradec Kralove","Hradec Kralove"],["Region Sjaelland Sygehus Nord, Koge Sygehus","Munck, Lars","丹麦","Koge","Koge"],["Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling","Burisch, Johan","丹麦","Hvidovre","Hvidovre"],["Sydvestjysk Region/Esbjerg Hospital","Dam Jensen, Michael","丹麦","Esbjerg","Esbjerg"],["Aalborg Hospital","Fallingborg, Jan","丹麦","Aalborg","Aalborg"],["Odense Universitetshospital (OUH) (Odense University Hospital)","Kjeldsen, Jens","丹麦","Odense","Odense"],["Hillerod Hospital, Hilleroed Sygehus","Leotta, Salvatore","丹麦","Hillerod","Hillerod"],["Hopital Nord Chu Saint-Etienne","Saint Etienne","法国","Saint Etienne","Saint Etienne"],["CHU De Clermont Ferrand - Hopital Estaing","Clermont-Ferrand","法国","Clermont-Ferrand","Clermont-Ferrand"],["Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois","Vandoeuvre les Nancy","法国","Vandoeuvre les Nancy","Vandoeuvre les Nancy"],["Hopital l'Archet 2","Nice Cedex 3","法国","Nice Cedex 3","Nice Cedex 3"],["Universitaetsklinikum Tuebingen","Buringer, Karsten","德国","Tuebingen","Tuebingen"],["Agaplesion Markus Krankenhaus","Dignass, Axel","德国","Frankfurt Am Main","Frankfurt Am Main"],["Praxis fur Gastroenterologie","Ehehalt, Robert","德国","Heidelberg","Heidelberg"],["Hamburger Forschungsinstitut Fuer Chronisch Entzuendliche Darmerkrankungen (HaFCED e.K.)","Howaldt, Stefanie","德国","Hamburg","Hamburg"],["University Hospital Of Ulm, Universitatsklinikum Ulm","Klaus, Jochen, G","德国","Ulm","Ulm"],["St. Marien- und St. Annastiftskrankenhaus","Kuehbacher, Tanja, D","德国","Ludwigshafen","Ludwigshafen"],["Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel","Schreiber, Stefan","德国","Kiel","Kiel"],["Sotiria General Hospital of Athens","Bamias, Giorgos","希腊","Athens","Athens"],["University Hospital of Heraklion","Koutroubakis, Ioannis, E","希腊","Heraklion","Heraklion"],["G.N.A. Gennimatas","Michalopoulos, Georgios","希腊","Athens","Athens"],["University General Hospital of Patras","Thomopoulos, Konstantinos","希腊","Patras","Patras"],["Evangelismos Hospital","Viazis,Nikolaos","希腊","Athens","Athens"],["Mohacsi Korhaz","Csizmadia, Csaba","匈牙利","Mohacs","Mohacs"],["Semmelweis Egyetem","Miheller, Pal","匈牙利","Budapest","Budapest"],["Pannonia Maganorvosi Centrum Kft.","Schnabel, Robert","匈牙利","Budapest","Budapest"],["Javorszky Odon Korhaz","Szaloki, Tibor","匈牙利","Vac","Vac"],["Clinexpert","Toth, Gabor Tamas","匈牙利","Budapest","Budapest"],["Assuta Ashdod University Hospital","Lahat-Tzok, Adi","以色列","Ashdod","Ashdod"],["The Chaim Sheba Medical centre - The Edmond and Lily Safra Children's Hospital","Levartovsky, Asaf","以色列","Ramat Gan","Ramat Gan"],["Soroka Mc","Schwartz, Doron","以色列","Beer Sheva","Beer Sheva"],["Shaare Zedek Medical Center","Shitrit, Ariella","以色列","Jerusalem","Jerusalem"],["IRCCS Istituto clinico humanitas - Humanitas Mirasole spa","Armuzzi, Alessandro","意大利","Rozzano","Rozzano"],["Azienda Ospedaliera San Camillo Forlanini","Cosintino, Rocco","意大利","Rome","Rome"],["Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital","Danese, Silvio","意大利","Milan","Milan"],["IRCCS A.O.U. Policlinico S.Orsola- Malpighi","Gionchetti, Paolo","意大利","Bologna","Bologna"],["Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello","Orlando, Ambrogio","意大利","Palermo","Palermo"],["Kitasato University Kitasato Institute Hospital","Asonuma, Kunio","日本","Minato-ku","Minato-ku"],["Saga University Hospital","Esaki, Motohiro","日本","Saga","Saga"],["Fukuoka University Hospital","Hirai, Fumihito","日本","Fukuoka","Fukuoka"],["Kyorin University Hospital","Hisamatsu, Tadakazu","日本","Mitaka-City","Mitaka-City"],["Toho University Sakura Medical Center","Matsuoka, Katsuyoshi","日本","Sakura","Sakura"],["Kansai Medical University Hospital","Naganuma, Makoto","日本","Hirakata","Hirakata"],["Sapporo Medical University Hospital","Nakase, Hiroshi","日本","Sapporo","Sapporo"],["The Jikei University Hospital","Saruta, Masayuki","日本","Minato","Minato"],["Severance Hospital, Yonsei University Health System","Cheon, Jae Hee","韩国","Seoul","Seoul"],["Yonsei University Wonju Severance Christian Hospital","Kim, Hyun Soo","韩国","Wonju","Wonju"],["Inje University Haeundae Paik Hospital","Kim, Tae-Oh","韩国","Busan","Busan"],["Samsung Medical Center","Kim, Young-Ho","韩国","Seoul","Seoul"],["Asan Medical Center (AMC)","Park, Sang Hyoung","韩国","Seoul","Seoul"],["St. Elisabeth Ziekenhuis","Laheij, Robert","荷兰","Tilburg","Tilburg"],["Vestre Viken HF - Baerum Sykehus","Astrup Hvattum, Stine","挪威","Drammen","Drammen"],["Akershus University Hospital","Brackmann, Stephan","挪威","Lorenskog","Lorenskog"],["Oslo Univeristy Hospital Ulleval Hospital","Kristensen, Vendel","挪威","Oslo","Oslo"],["Medrise sp. z o.o","Danilkiewicz, Wit, C","波兰","Lublin","Lublin"],["Centrum Medyczne Medyk Sp. z o.o. Sp. K.","Filip, Rafal","波兰","Rzeszow","Rzeszow"],["Twoja Przychodnia - Szczecinskie Centrum Medyczne","Gawdis-Wojnarska, Beata","波兰","Szczecin","Szczecin"],["WIP Warsaw IBD Point Profesor Kierkus","Kierkus, Jaroslaw","波兰","Warsaw","Warsaw"],["Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy","Klopocka, Maria","波兰","Bydgoszcz","Bydgoszcz"],["Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie","Kopon, Adam","波兰","Torun","Torun"],["Korczowski Bartosz, Gabinet Lekarski","Korczowski, Bartosz","波兰","Rzeszow","Rzeszow"],["Centrum Medyczne Melita Medical","Leszczyszyn, Jaroslaw","波兰","Wroclaw","Wroclaw"],["Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi","Malecka-Wojciesko, Ewa","波兰","Lodz","Lodz"],["Centrum Medyczne Pratia Gdynia","Potrzebowski, Wojciech","波兰","Gdynia","Gdynia"],["H-T. Centrum Medyczne Sp. z o.o. Sp.k.","Romanczyk, Tomasz","波兰","Tychy","Tychy"],["Panstwowy Instytut Medyczny MSWiA","Rydzewska-Wyszkowska, Grazyna","波兰","Warszawa","Warszawa"],["PlanetMed Sp. z o.o.","Wozniak-Stolarska, Barbara","波兰","Wroclaw","Wroclaw"],["Spital Clinic Dr I Cantacuzino","Busuioc, Bogdan","罗马尼亚","Bucharest","Bucharest"],["Delta Health Care","Chioncel, Camelia","罗马尼亚","Bucuresti","Bucuresti"],["Spitalul de Oncologie Monza - Soseaua Gheorghe Ionescu Sisesti","Craciun, Ion Eugeniu","罗马尼亚","Bucuresti","Bucuresti"],["Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis","Goldis, Adrian Eugen, A","罗马尼亚","Timisoara","Timisoara"],["Clinical Hospital Colentina-Spitalul Clinic Colentina","Mateescu, Radu Bogdan","罗马尼亚","Bucharest","Bucharest"],["Clinica Medicum","Voiosu, Theodor-Alexandru","罗马尼亚","Bucharest","Bucharest"],["Fakultna nemocnica F. D. Roosevelta","Balaz, Jozef","斯洛伐克","Banska Bystrica","Banska Bystrica"],["Fakultna Nemocnica s poliklinikou Nove Zamky","Durina, Juraj","斯洛伐克","Nove Zamky","Nove Zamky"],["Endomed","Fedurco, Miroslav","斯洛伐克","Kosice","Kosice"],["Cliniq s. r. o.","Hlavaty, Tibor","斯洛伐克","Bratislava","Bratislava"],["Accout Center s.r.o., Gastroenterologicka ambulancia","Horvath, Frantisek","斯洛伐克","Sahy","Sahy"],["China Medical University Hospital","Chou, Jen-Wei","中国台湾","Taichung City","Taichung City"],["National Taiwan University Hospital (NTUH)","Wei, Shu-Chen","中国台湾","Taipei City","Taipei City"],["Changhua Christian Hospital (CCH)","Yen, Hsu-Heng","中国台湾","Changhua City","Changhua City"],["South Eastern Health and Social Care Trust - The Ulster Hospital","Agnew, Paul","英国","Belfast","Belfast"],["Clinical Research Centre - Barts Health NHS Trust","Parkes, Gareth, C","英国","London","London"],["St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust","Samaan, Mark, A","英国","London","London"],["Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust","Subramanian, Sreedhar","英国","Cambridge","Cambridge"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["浙江大学医学院附属邵逸夫医院医学伦理委员会","同意","2025-04-14"]]

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: 12 ； 国际: 207 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 79 ；
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：2024-03-29；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2024-06-04；
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；