北京TAK-755II期临床试验-TAK-755 治疗急性缺血性卒中的 II 期研究

登记号	CTR20261054	试验状态	进行中
申请人联系人	闫美娜	首次公示信息日期	2026-03-18
申请人名称	Takeda Development Center Americas, Inc./ 武田（中国）国际贸易有限公司/ Takeda Manufacturing Austria AG/ Clinigen Clinical Supplies Management GmbH;Clinigen Clinical Supplies Management Inc.

登记号	CTR20261054
相关登记号	暂无
药物名称	TAK-755
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	急性缺血性卒中（AIS）
试验专业题目	一项评估 TAK-755 对急性缺血性卒中的安全性、耐受性和疗效的 II 期、随机、双盲、安慰剂对照研究
试验通俗题目	TAK-755 治疗急性缺血性卒中的 II 期研究
试验方案编号	TAK-755-2002	方案最新版本号	方案修订案1
版本日期:	2025-12-01	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"],["Takeda Manufacturing Austria AG"],["Clinigen Clinical Supplies Management GmbH;Clinigen Clinical Supplies Management Inc."]]
联系人姓名	闫美娜	联系人座机	010-84147680	联系人手机号
联系人Email	mona.yan@takeda.com	联系人邮政地址	北京市-北京市-朝阳区新源南路8号启皓北京西塔二层	联系人邮编	100027

评估TAK-755在未接受抗凝伴随治疗的参与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 80岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	[["参与者或法定授权代表在开始任何试验程序之前已提供知情同意书。"],["签署知情同意收时年满18-80岁（含）。国家特定标准见第13.4节。"],["临床诊断为急性缺血性卒中（AIS）"],["卒中症状在入组前24小时内出现。如果最后发现状态正常的时间在入组前24小时内，则醒后卒中参与者也可入组试验。"],["美国国立卫生研究院卒中量表评分6-25分，提示中度至重度卒中。"],["AIS起病前改良Rankin量表评分估计值<2，表示没有明显的失能。"],["影像学证据显示存在导致 AIS 的闭塞，包括：颅内颈内动脉（ICA）、M1、M2、M3、M4、A1、A2、A3。"],["CT 或 MR 显示存在 可挽救的脑组织（salvageable tissue）"],["体征和症状符合前循环卒中。"]]
排除标准	[["既往史n体重 >130公斤或 <40公斤。"],["过去90天内有重度外伤性脑损伤史。"],["颅内出血史。"],["有颅内肿瘤病史（小型脑膜瘤除外）。"],["过去90天内卒中史。"],["过去90天内有颅内或椎管内手术史。"],["过去14天内接受过大手术或重度外伤。"],["脑淀粉样血管病史。"],["有全身性恶性肿瘤病史，局部切除且切缘干净的基底细胞或鳞状细胞皮肤癌除外。"],["诊断为严重、晚期或终末期疾病，且预期寿命少于 1 年"],["过去90天内参加过其他干预性临床试验"],["已知对 TAK-755 或其成分有危及生命的超敏反应"],["既往接受过 TAK-755 给药"],["过去30天内使用过卡普拉珠单抗"],["过去14天内使用过含血管性血友病因子的产品"],["根据研究者的判断，基线（在本次AIS事件发生前）存在妨碍理解试验性质、范围及可能后果的情况。"],["当前卒中管理。已使用（静脉注射或动脉内注射）阿替普酶或替奈普酶治疗本次AIS事件，或在获批国家/地区已使用尿激酶原或瑞替普酶治疗本次AIS事件。"],["根据试验中心的标准临床指南和直接可及性，参与者有资格接受静脉溶栓（阿替普酶或替奈普酶，或在获批国家/地区使用尿激酶原或瑞替普酶）给药治疗本次AIS事件"],["根据适用条件及直接可及性，计划对本次AIS事件进行EVT"],["AIS事件发生时癫痫发作"],["随机化前持续血压升高（收缩压≥185 mmHg或舒张压≥110 mmHg）"],["血糖 <50 mg/dL 或 >400 mg/dL"],["目前的医疗状况。活动性未控制的出血"],["存在出血倾向或其他会造成显著出血风险的状况"],["无法进行 MRI 或 CT"],["AIS 症状迅速改善"],["责任性慢性颅内动脉闭塞"],["责任性颅外ICA完全闭塞"],["存在脓毒性栓子或细菌性心内膜炎证据"],["研究者认为可能对参与者构成额外风险的另一种具有临床意义的伴随疾病"],["怀孕、哺乳或研究者认为无法遵守方案中规定的节育方法或禁欲"],["影像学。成像质量差，无法根据试验方案进行判读"],["显著颅内占位效应或中线偏移的证据"],["存在>1个供血区闭塞的证据"],["急性或慢性颅内出血的证据"],["存在大脑中动脉供血管区早期缺血性改变广泛（范围估计>1/3）的证据"],["存在颅内肿瘤（偶发的小型脑膜瘤除外）、大脑动脉瘤或动静脉畸形的证据"],["实验室。血小板计数<50,000/mm3。"],["其他。被研究者确定为可能无法或不愿配合试验程序。"]]

试验药	[["中文通用名:TAK-755 英文通用名:TAK-755 商品名称:NA","剂型:冻干制剂 规格:NA 用法用量:NA 用药时程:NA"]] 序号 名称 用法
对照药	[["中文通用名:TAK-755安慰剂 英文通用名:TAK-755Placebo 商品名称:NA","剂型:冻干制剂 规格:NA 用法用量:NA 用药时程:NA"]] 序号 名称 用法

主要终点指标及评价时间

[["A阶段和B阶段：试验药物给药后120小时内出现的由海德堡分类系统定义的症状性颅内出血（sICH）的参与者比例。","给药后 至 120 小时","安全性指标"]] 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

[["A阶段：90天内发生治疗相关和不相关的治疗中出现的不良事件（TEAE）和严重不良事件（SAE）的参与者比例。","给药后90天内","安全性指标"],["A阶段：90天内发生重度TEAE的参与者比例。","给药后90天内","安全性指标"],["A阶段：90天内发生危及生命的不良事件（AE）的参与者比例。","给药后90天内","安全性指标"],["A阶段：发生特别关注的AE（AESI）的参与者比例。","给药后90天内","安全性指标"],["A阶段：在生命体征、血生化和血常规方面发生有临床意义变化的参与者比例。","给药后90天内","安全性指标"],["A阶段：第30-90天时ADAMTS13结合和中和抗体的发生率。","给药后30天-90天内","安全性指标"],["A阶段：90天内的全因死亡率。","给药后90天内","安全性指标"],["A阶段和B阶段：第90天时改良Rankin量表评分（mRS）为0-1的参与者比例","给药后90天内","有效性指标"],["A阶段和B阶段：第90天mRS评分为0-2的参与者比例。","给药后90天内","有效性指标"],["A阶段和B阶段：第90天mRS按分数的分布。","给药后90天内","有效性指标"],["A阶段和B阶段：24小时 n美国国立卫生研究院卒中量表（NIHSS）评分较基线的变化。","24小时内","有效性指标"],["A阶段和B阶段：24小时再通的参与者比例，再通定义为动脉闭塞病变（AOL）评分为3的完全再通。","24小时内","有效性指标"],["A阶段和B阶段：24小时再灌注的参与者比例，定义为可逆缺血组织（半暗带）的体积较基线减少 >90%。","24小时","有效性指标"],["A阶段和B阶段：72小时或出院时（如果早于 72 小时）的最终梗死体积","72小时或出院时","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	王拥军	学位	医学博士	职称	主任医师
	电话	010-59978538	Email	yongjunw@hotmail.com	邮政地址	北京市-北京市-丰台区南四环西路119号
	邮编	100070	单位名称	首都医科大学附属北京天坛医院

[["首都医科大学附属北京天坛医院","王拥军","中国","北京市","北京市"],["临沂市人民医院","王自然","中国","山东省","临沂市"],["临汾市中心医院","戴红果","中国","山西省","临汾市"],["徐州医科大学附属医院","程言博","中国","江苏省","徐州市"],["南阳南石医院","肖小华","中国","河南省","南阳市"],["山东大学齐鲁医院","吴伟","中国","山东省","济南市"],["聊城市人民医院","郭栋","中国","山东省","聊城市"],["国药同煤总医院","王俊海","中国","山西省","大同市"],["Groupe sante CHC - Clinique du MontLegia","Philippe Desfontaines","比利时","Liege","Liege"],["Universitair Ziekenhuis Gent (Belgium,Ghent)","Dimitri Hemelsoet","比利时","Ghent","Ghent"],["Ziekenhuis Oost-Limburg","Sam Van Boxstael","比利时","Limburg","Limburg"],["AZ Groeninge","Peter Vanacker","比利时","WVL","WVL"],["Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman","Julien Ly","比利时","Liege","Liege"],["Hospital Moinhos de Vento","Leonardo Augusto Carbonera","巴西","Rio Grande do Sul","Rio Grande do Sul"],["Porto Alegre Clinical Hospital (HCPA)","Sheila Cristina Ouriques Martins","巴西","Rio Grande do Sul","Rio Grande do Sul"],["Hospital Sao Paulo / Escola Paulista de Medicina da Universidade Federal de Sao Paulo (EPM/UNIFESP)","Gisele Sampaio Silva","巴西","SP","SP"],["Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina Campus de Botucatu","Rodrigo Bazan","巴西","Sao Paulo","Sao Paulo"],["Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto","Mariana Neves Marques Battaglini","巴西","Sao Paulo","Sao Paulo"],["Universidade Estadual de Campinas (UNICAMP)","Wagner Mauad Avelar","巴西","Campinas","Campinas"],["Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - HC FMRP- USP address:","Octavio Marques Pontes-Neto","巴西","Sao Paulo","Sao Paulo"],["Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Raymond-Poincare","Sandrine Deltour Bouard","法国","Garche","Garche"],["Hopital Lariboisiere","Mazighi Mikael","法国","Paris","Paris"],["Groupe Hospitalier Bichat Claude Bernard","Elena Meseguer","法国","Paris","Paris"],["Bicetre Hospital","Christian Denier","法国","Le Kremlin-Bicetre","Le Kremlin-Bicetre"],["CHU Bordeaux, CHU Pellegrin","Igor Sibon","法国","Bordeaux","Bordeaux"],["Universitaetsmedizin Goettingen","Ilko Maier","德国","Niedersachsen","Niedersachsen"],["Universitaetsklinikum Heidelberg (UKHD)","Jan Purrucker","德国","Baden-Wurttemberg","Baden-Wurttemberg"],["Goethe-Universitaet-Universitaetsmedizin Frankfurt-Zentrum der Neurologie und Neurochirurgie (ZNN)","Jan Hendrik Schaefer","德国","Hesse","Hesse"],["Universitaetsklinikum Tuebingen","Sven Poli","德国","Baden-Wurttemberg","Baden-Wurttemberg"],["Charite – Universitatsmedizin Berlin","Christian Nolte","德国","Berlin","Berlin"],["Klinikum Ernst von Bergmann","Andrea Rocco","德国","Brandeburg","Brandeburg"],["Athens Navy Hospital","Michalis Ioakeimidis","希腊","Athens","Athens"],["AHEPA University General Hospital of Thessaloniki","Theodoros Karapanagiotidis","希腊","Thessaloniki","Thessaloniki"],["University General Hospital Attikon","Georgios Tsivgoulis","希腊","Athens","Athens"],["University Hospital of Alexandroupolis","Konstantinos Vadikolias","希腊","Alexandroupolis","Alexandroupolis"],["Amrita Institute Of Medical Sciences and Research Centre","Vivek Nambiar","印度","Kerala","Kerala"],["Manipal Hospital Mukundapur","Jayanta Roy","印度","West Bengal","West Bengal"],["Department of Neurology","Ayush Agarwal","印度","Ansari Nagar","Ansari Nagar"],["AES - AS - KLES Dr Prabhakar Kore Hospital and Medical Research Centre","Aralikatte Saroja","印度","Kamataka","Kamataka"],["Christian Medical College, Ludhianana","Jeyaraj Pandian","印度","Punjab","Punjab"],["Bedfordshire Hospitals NHS Foundation Trust","Lakshmanan Sekaran","英国和北爱尔兰","Bedford","Bedford"],["Derby Hospitals NHS Foundation Trust","Timothy England","英国和北爱尔兰","Derbyshire","Derbyshire"],["Imperial College Healthcare NHS Trust","Peter Kalladka","英国和北爱尔兰","London","London"],["NHS Greater Glasgow and Clyde","Amith Sitaram","英国和北爱尔兰","Lanarkshire","Lanarkshire"],["University of Glasgow - PPDS","Terence Quinn","英国和北爱尔兰","Lanarkshire","Lanarkshire"],["Aberdeen Royal Infirmary","Mary Mcleod","英国和北爱尔兰","Scotland","Scotland"],["University of California San Francisco","Anthony Kim","美国","CA","CA"],["Massachusetts General Hospital","W. Taylor Kimberly","美国","MA","MA"],["Vanderbilt University Medical Center","Michael Froehler","美国","Tennessee","Tennessee"],["Barrow Brain and Spine","Ashtosh Jadhav","美国","AZ","AZ"],["University of Arizona","Firas Kaddouh","美国","Arizona","Arizona"],["University of South Florida","Swetha Renati","美国","FL","FL"],["University of Pittsburgh Medical Center","Raul Nogueira","美国","Pennsylvania","Pennsylvania"],["Chattanooga Center for Neurologic Research","Thomas Devlin","美国","Tennessee","Tennessee"],["55tStanford University School of MedicinetGregory Alberst美国tCalifornia","Gregory Albers","美国","California","California"],["HCA Houston Healthcare - North Cypress","Sushrut Dharmadhikari","美国","TX","TX"],["Neurology Consultants of Dallas, PA","Ryan Cheung","美国","Texas","Texas"],["University of Buffalo","Marilou Ching","美国","NY","NY"],["Fukuoka Wajiro Hospital","Kozo Fukuyama","日本","Fukuoka","Fukuoka"],["Rinku General Medical Center","Yasushi Hagihara","日本","Osaka","Osaka"],["Nagano Municipal Hospital","Yoshikazu Kusano","日本","Nagano","Nagano"],["Kotobuki Tominaga Hospital","Ko Matsuda","日本","Osaka","Osaka"],["Saiseikai Fukuoka General Hospital","Kazutaka Sonoda","日本","Chuo？ku, Fukuoka","Chuo？ku, Fukuoka"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["首都医科大学附属北京天坛医院医学伦理委员会","同意","2026-02-12"]]

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: 55 ； 国际: 222 ；
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；