一、题目和背景信息
| 登记号 |
CTR20253059 |
| 相关登记号 |
暂无
|
| 药物名称 |
TQJ230 |
| 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 |
降低心血管风险 |
| 试验专业题目 |
一项在完成母试验Lp(a)HORIZON的参与者中评价pelacarsen（TQJ230）长期安全性和耐受性的单臂、多中心、开放标签扩展（OLE）试验 |
| 试验通俗题目 |
一项评价pelacarsen（TQJ230）长期安全性和耐受性的开放标签扩展（OLE）试验 |
| 试验方案编号 |
CTQJ230A12301E1 |
方案最新版本号
|
V00（原始方案） |
| 版本日期: |
2024-12-19 |
方案是否为联合用药 |
否 |
二、申请人信息
| 申请人名称 |
[["Novartis Pharma AG"],["诺华（中国）生物医学研究有限公司"],["Novartis Pharma Stein AG"]] |
| 联系人姓名 |
诺华医学热线（临床登记） |
联系人座机 |
400-6213132 |
联系人手机号 |
|
| 联系人Email |
clinicaltrial.cn@novartis.com |
联系人邮政地址 |
北京市-北京市-朝阳区针织路23号 |
联系人邮编 |
100026 |
三、临床试验信息
1、试验目的
在已完成母研究Lp(a)HORIZON的Lp(a)升高并确诊CVD的参与者中评价pelacarsen（TQJ230）的长期安全性和耐受性
2、试验设计
| 试验分类 |
安全性和有效性 |
试验分期 |
III期
|
设计类型 |
单臂试验
|
| 随机化 |
非随机化
|
盲法 |
开放
|
试验范围 |
国际多中心试验
|
3、受试者信息
| 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 |
[["参与者已在开始任何研究特定活动/程序之前提供知情同意书"],["已完成母研究且仍在接受分配的试验药品的参与者。"]]
|
| 排除标准 |
[["在母研究停用研究用药品的参与者"],["使参与者处于风险中或干扰研究参与的疾病、状况"],["参与者在开放标签治疗期前正在接受另一种研究药物或器械。"],["对研究药物过敏。"],["筛选访视时HIV筛查、丙型肝炎抗体筛查或乙型肝炎表面抗原检测呈阳性。"],["妊娠期或哺乳期女性"],["育龄期女性，除非使用高效避孕方法"]]
|
4、试验分组
| 试验药 |
| 序号 |
名称 |
用法 |
[["中文通用名:TQJ230
英文通用名:TQJ230
商品名称:NA","剂型:预装型注射液
规格:80mg/0.8mL
用法用量:皮下注射；每月一次
用药时程:至少24个月"]]
|
| 对照药 |
|
5、终点指标
| 主要终点指标及评价时间 |
| 序号 |
指标 |
评价时间 |
终点指标选择 |
[["治疗期间出现的不良事件（TEAE）n治疗期间出现的严重不良事件（TESAE）n因TEAE/TESAE终止治疗n特别关注的TEAEn以下指标的观察值或较基线变化：n安全性实验室指标n生命体征","持续进行","安全性指标"]]
|
| 次要终点指标及评价时间 |
| 序号 |
指标 |
评价时间 |
终点指标选择 |
[["自母研究基线至首次发生4P-MACE的时间n自OLE研究基线至首次发生4P-MACE的时间n自母研究基线后随时间推移的4P-MACE累计数n自OLE研究基线后随时间推移的4P-MACE累计数","持续进行","有效性指标"],["Lp(a)的观察值和较母研究基线的变化nLp(a)的观察值和较OLE研究基线的变化","持续进行","有效性指标"]]
|
四、研究者信息
1、主要研究者信息
| 1 |
姓名 |
马长生 |
学位 |
医学博士 |
职称 |
教授 |
| 电话 |
13901357404 |
Email |
chshma@vip.sina.com |
邮政地址 |
北京市-北京市-朝阳区安贞路2号 |
| 邮编 |
100029 |
单位名称 |
首都医科大学附属北京安贞医院 |
2、各参加机构信息
| 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安贞医院","马长生","中国","北京市","北京市"],["复旦大学附属华山医院","李勇","中国","上海市","上海市"],["浙江大学医学院附属邵逸夫医院","傅国胜","中国","浙江省","杭州市"],["东南大学附属中大医院","汤成春","中国","江苏省","南京市"],["广东省人民医院","陈纪言","中国","广东省","广州市"],["包头市中心医院","卢耀军","中国","内蒙古自治区","包头市"],["天津医科大学总医院","杨清","中国","天津市","天津市"],["天津市人民医院","姚朱华","中国","天津市","天津市"],["北京大学第三医院","李昭屏","中国","北京市","北京市"],["苏州大学附属第一医院","蒋廷波","中国","江苏省","苏州市"],["中南大学湘雅三医院","蒋卫红","中国","湖南省","长沙市"],["中国医科大学附属盛京医院","李晓东","中国","辽宁省","沈阳市"],["吉林大学第一医院","郑杨","中国","吉林省","长春市"],["兰州大学第二医院","白锋","中国","甘肃省","兰州市"],["首都医科大学附属北京友谊医院","沈爱东","中国","北京市","北京市"],["辽宁省人民医院","刘莹","中国","辽宁省","沈阳市"],["西安交通大学第一附属医院","袁祖贻","中国","陕西省","西安市"],["中山大学附属第一医院","董吁钢","中国","广东省","广州市"],["四川大学华西医院","祝烨","中国","四川省","成都市"],["泰达国际心血管病医院","张健","中国","天津市","天津市"],["泰达国际心血管病医院","刘志刚","中国","天津市","天津市"],["上海交通大学医学院附属瑞金医院","朱云鹏","中国","上海市","上海市"],["温州医科大学附属第一医院","黄周青","中国","浙江省","温州市"],["北京协和医院","张抒扬","中国","北京市","北京市"],["哈尔滨医科大学附属第一医院","李悦","中国","黑龙江省","哈尔滨市"],["中南大学湘雅二医院","彭道泉","中国","湖南省","长沙市"],["济南市中心医院","苏国海","中国","山东省","济南市"],["浙江省人民医院","屈百鸣","中国","浙江省","杭州市"],["江苏省人民医院","李殿富","中国","江苏省","南京市"],["中南大学湘雅医院","余再新","中国","湖南省","长沙市"],["同济大学附属东方医院","李莹","中国","上海市","上海市"],["佛山市第一人民医院","梁茜","中国","广东省","佛山市"],["南京医科大学第二附属医院","章海燕","中国","江苏省","南京市"],["上海市同济医院","刘学波","中国","上海市","上海市"],["厦门大学附属心血管病医院","戴翠莲","中国","福建省","厦门市"],["徐州医科大学附属医院","朱红","中国","江苏省","徐州市"],["大连医科大学附属第一医院","姜一农","中国","辽宁省","大连市"],["新疆医科大学第一附属医院","马依彤","中国","新疆维吾尔自治区","乌鲁木齐市"],["Tosei General Hospital","Hiroshi Asano","Japan","Aichi","Seto-city"],["Hospital Nuestra Senora De Valme","Antonio Reyes Dominguez","Spain","Andalucia","Sevilla"],["Hospital Universitario Reina Sofia","Jose Lopez Miranda","Spain","Andalucia","Cordoba"],["Hospital Virgen Del Rocio","Luis Matias Beltran Romero","Spain","Andalucia","Sevilla"],["Hospital Pablo Tobon Uribe","Juan Carlos Chavarriaga","Colombia","Antioquia","Medellin"],["Hirosaki University Hospital","Hirofumi Tomita","Japan","Aomori","Hirosaki"],["Medizinische Univ Klinik Graz","Harald Sourij","Austria","Austria","Graz"],["MEDITSINSKI TSENTAR MEDKONSULT PLEVEN","Maria Tzekova","Bulgaria","Bulgaria","Pleven"],["DCC Sv Georgi Pobedonosets EOOD","Daniela Vateva","Bulgaria","Bulgaria","Burgas"],["H U Marques de Valdecilla e Idival","Jose Luis Hernandez Hernandez","Spain","Cantabria","Santander"],["Funabashi Municipal Medical Center","Shigeru Fukuzawa","Japan","Chiba","Funabashi"],["Chiba-Nishi General Hospital","Takehiko Kuramochi","Japan","Chiba","Matsudo-city"],["Asahi General Hospital","Shunichi Kushida","Japan","Chiba","Asahi"],["Kardio Chlumec s r o","Martin Wiendl","Czech Republic","Chlumec nad Cidlinou","Chlumec nad Cidlinou"],["IPS Centro Cientifico Asistencial","Jose Luis Accini Mendoza","Colombia","Colombia","Barranquilla"],["Kardiologicka ambulance Trutnov","Richard Ferkl","Czech Republic","CZE","Trutnov"],["Policska Nemonice S R O","Pavel Koleckar","Czech Republic","CZE","Policska"],["Pardubicka krajska nemocnice","Jiri Vondrak","Czech Republic","Czech Republic","Pardubice"],["Kardiologicka interni a cevni ambulance BENEDOR","Miroslav Homza","Czech Republic","Czech Republic","Ostrava"],["Kromerizska nemocnice a s","Pavel Trestik","Czech Republic","Czech Republic","Kromeriz"],["Kardiobusak S R O","Ladislav Busak","Czech Republic","Czech Republic","Louny"],["Kardiologie","Jiri Kuchar","Czech Republic","Czech Republic","Cesky Krumlov"],["Fakultni nemocnice U Svate Anny","Michal Rezek","Czech Republic","Czech Republic","Brno"],["Kardiologicka a Interni Ambulance Liberec s.r.o","Peter Telekes","Czech Republic","Czech Republic","Liberec V Kristianova"],["Keimyung Univ Dongsan Medical Ctr","Seung Ho Hur","Korea","Dalseo gu","Daegu"],["Hospital San Pedro de Alcantara","Jose Javier Gomez Barrado","Spain","Extremadura","Caceres"],["Kokura Memorial Hospital","Kenji Ando","Japan","Fukuoka","Kitakyushu-city"],["Hospital Clinico Univ De Santiago","Jose Ramon Gonzalez Juanatey","Spain","Galicia","Santiago de Compostela"],["Yonsei Uni Wonju Severance hospital","ByungSu Yoo","Korea","Gangwon-do","Wonju"],["Medizentrum Essen Borbeck","Axel Schaefer","Germany","Germany","Essen"],["Ogaki Municipal Hospital","Itsuro Morishima","Japan","Gifu","Ogaki-city"],["University General Hospital of Larissa","Georgios Ntaios","Greece","GR","Larissa"],["Ajou University Medical Center","Myeong-Ho Yoon","Korea","Gyeonggi-Do","Suwon"],["National Hospital Organization Kure Medical Center","Hiroshi Sugino","Japan","Hiroshima","Hiroshima"],["Tsuchiura Kyodo General Hospital","Tsunekazu Kakuta","Japan","Ibaraki","Tsuchiura"],["Komatsu Municipal Hospital","Toshinori Higashikata","Japan","Ishikawa","Komatsu"],["Kanazawa University Hospital","Masayuki Takamura","Japan","Ishikawa","Kanazawa"],["Cardiomed srl","Constantin Militaru","Romania","Jud Dolj","Craiova"],["Kagawa Prefectural Central Hospital","Masayuki Doi","Japan","Kagawa","Takamatsu-city"],["Kitasato University Hospital","Junya Ako","Japan","Kanagawa","Sagamihara-city"],["Second Kawasaki Saiwai Clinic","Kei Hatori","Japan","Kanagawa","Kawasaki"],["Korea University Guro Hospital","Seungwoon Rha","Korea","Korea","Seoul"],["C K Kardiomed M Zabowka E Zabowka","Maciej Zabowka","Poland","Malopolskie","Tarnow"],["Sendai Kousei Hospital","Tsuyoshi Isawa","Japan","Miyagi","Sendai city"],["Miyazaki Medical Association Hospital","Yoshisato Shibata","Japan","Miyazaki","Miyhazaki"],["St. Vinzenz-Hospital","Jan Pulz","Germany","Nordrhein-Westfalen","Koeln"],["Osaka Keisatsu Hospital","Yoshiharu Higuchi","Japan","Osaka","Osaka-city"],["City Polyclinic 106","Danila Chizhov","Russia","Russia","Saint Petersburg"],["Saitama Sekishinkai Hospital","Taro Shibasaki","Japan","Saitama","Sayama-city"],["Sayama General Clinic","Taro Shibasaki","Japan","Saitama","Sayama-city"],["Fundacion CV de Colombia","Robinson Sanchez Garcia","Colombia","Santander","Bucaramanga"],["MVZ am Kuechwald GmbH","Jan Ernstberger","Germany","Saxony","Chemnitz"],["Universitaetsklinikum Magdeburg","Katrin Borucki","Germany","Saxony-Anhalt","Magdeburg"],["Dong A University Hospital","Jongsung Park","Korea","Seo-gu","Busan"],["Omihachiman Community Medical Center","Takuo Nakagami","Japan","Shiga","Omihachiman"],["Angionika s r o","Monika Podperova","Czech Republic","Slany","Slany"],["Minamino Cardiovascular Hospital","Yoshiki Hata","Japan","Tokyo","Hachioji"],["Toho University Omori Medical Center","Takanori Ikeda","Japan","Tokyo","Ota-ku"],["Tokyo Eki Center building Clinic","Arihiro Kiyosue","Japan","Tokyo","Chuo-ku"],["Centro de Investigaciones Clinicas","Maria Villegas","Colombia","Valle del Cauca","Cali"],["Fundacion Valle de Lili","Pastor Olaya","Colombia","Valle del Cauca","Cali"]]
五、伦理委员会信息
| 序号 |
名称 |
审查结论 |
批准日期/备案日期 |
[["北京安贞医院临床研究伦理委员会","同意","2025-07-24"]]
六、试验状态信息
1、试验状态
进行中（尚未招募）
2、试验人数
| 目标入组人数 |
国内: 388 ；
国际: 5700 ； |
| 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； |
3、受试者招募及试验完成日期
| 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； |
