西安TQJ230注射液III期临床试验-Pelacarsen开放标签后续承接扩展项目

登记号	CTR20262739	试验状态	进行中
申请人联系人	诺华医学热线（临床登记）	首次公示信息日期	2026-07-16
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

登记号	CTR20262739
相关登记号	暂无
药物名称	TQJ230注射液
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	一项在确诊为ASCVD且Lp(a) 升高的参与者中评价开放标签pelacarsen的长期安全性和耐受性的后续承接扩展项目（REP）
试验通俗题目	Pelacarsen开放标签后续承接扩展项目
试验方案编号	CTQJ230A12305B	方案最新版本号	v00
版本日期:	2025-02-05	方案是否为联合用药	否

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	17601160922
联系人Email	mic.china@novartis.com	联系人邮政地址	北京市-北京市-朝阳区针织路23号中国人寿金融中心5层	联系人邮编	100022

本研究的目的是收集额外的安全性数据，并为完成母研究Lp(a) EXPANSION或Lp(a) ADD-VANTAGE的参与者提供试验后供药。

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

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	[["在参与研究之前必须获得已签署的知情同意书。"],["完成母研究并在完成时接受分配的研究治疗的参与者。"]]
排除标准	[["在母研究中根据方案强制要求或由于不良事件而永久终止研究治疗的参与者。"],["研究者认为可能使参与者面临风险或影响其参与研究的任何医学状况。"],["在开放标签治疗期前正在接受另一种试验药物或器械的参与者。"],["已知对研究药物过敏，且研究者认为不适合参加研究的参与者。"]]

试验药	[["中文通用名:TQJ230注射液 英文通用名:TQJ230injection 商品名称:NA","剂型:预装式注射液 规格:不公示 用法用量:皮下注射 用药时程:多次给药"]] 序号 名称 用法
对照药	暂未填写此信息 序号 名称 用法

主要终点指标及评价时间	[["不良事件（AE）或严重不良事件（SAE）的发生率","48个月","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	[["Lp(a) 的观察值和较母研究基线的变化","核心研究基线，第3、12、24、36和48个月","有效性指标"],["Lp(a) 的观察值和较REP研究基线的变化","REP研究基线，第3、12、24、36和48个月","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	袁祖贻	学位	医学博士	职称	主任医师
	电话	029-853236664	Email	zuyiyuan9505@163.com	邮政地址	陕西省-西安市-雁塔区小寨路街道雁塔西路277号
	邮编	710061	单位名称	西安交通大学第一附属医院

[["西安交通大学第一附属医院","袁祖贻","中国","陕西省","西安市"],["宁夏医科大学总医院","马学平","中国","宁夏回族自治区","银川市"],["上海交通大学医学院附属瑞金医院","陈桢玥","中国","上海市","上海市"],["济宁医学院附属医院","曹勇","中国","山东省","济宁市"],["北京医院","于雪","中国","北京市","北京市"],["Taipei Veterans General Hospital","Kang Ling Wang","中国台湾","台北","台北"],["National Taiwan University Hospital","Tzung-Dau Wang","中国台湾","台北","台北"],["North Tyneside General Hospital","David Ripley","英国","Rake Lane","Rake Lane"],["Manchester Royal Infirmary","Handrean Soran","英国","Manchester","Manchester"],["Barts and the London School of Med","Manish Saxena","英国","london","london"],["St Richard's Hospital","Kate Shipman","英国","West Sussex","Chichester"],["Freeman Hospital","Azfar Zaman","英国","Newcastle","Newcastle Upon Tyne"],["Hammersmith Hospital","Jaimini Cegla","英国","london","london"],["Hammersmith Hospital","Alexis Gutierrez","美国","FL","Miami Lakes"],["Hammersmith Hospital","Felton Anderson","美国","MD","Fort Washington"],["AB Clinical Trials","Atoya Adams","美国","NV","Las Vegas"],["Proactive Clinical Research","David Mishkin","美国","FL","Fort Lauderdale"],["Excel Medical Clinical Trials LLC","Michael Hafran","美国","FL","Boca Raton"],["FXM Clin Res Miramar LLC","Yaneth Trujillo","美国","FL","Miramar"],["Virginia Heart","Tariq Haddad","美国","VA","Falls Church"],["Southern Clin Research Clinic","Ernest Thompson","美国","LA","Zachary"],["Dallas Heart and Vascular Consultants PA","Ahmed A Arif","美国","TX","Houston"],["AA MRC LLC","Ahmed A Arif","美国","MI","Flint"],["NORTH HILLS MEDICAL RESEARCH INC","John Gabriel.","美国","TX","North Richland Hills"],["Cardiovascular Associates Research","Dale Presser","美国","LA","Covington"],["Cardiology Partners Clinical Research Institute","Duccio Baldari","美国","FL","Wellington"],["Clinical Research of South Nevada","Roger Estevez","美国","NV","Las Vegas"],["Apex Cardiology Research Associates of Jackson","Mohsin Alhaddad","美国","TN","Jackson"],["Clinical Trials of Texas","Douglas Denham","美国","TX","San Antonio"],["DBC Research USA","Alvaro Murcia","美国","FL","Pembroke Pines"],["Angiocardiac Care of Texas PA","Amin Karim","美国","TX","Houston"],["Parkway Medical Center","James Sullivan","美国","AL","Birmingham"],["Chicago Clinical Research Inst","Dennis Levinson","美国","IL","Chicago"],["Dallas Heart and Vascular Consultants PA","Syed Humayun Naqvi","美国","TX","Houston"],["Javara Research","Amine Segueni","美国","NC","NC"],["National Research Institute","Raul Alonso","美国","FL","Hialeah"],["Finlay Medical Research","Lilia Rodriguez-Ables","美国","FL","Miami"],["CAIMED Center","Elizabeth Barranco","美国","PR","Ponce"],["Atlanta Heart Specialists LLC","David Suh","美国","GA","Tucker"],["CV Ins of the South","Siby George Ayalloore","美国","LA","Opelousas"],["CTMD Research","Luis Castil","美国","FL","Palm Springs"],["METROPOLITAN CARDIOVASCULAR CONSULTANTS LLC","Ayim Akyea-Djamson","美国","MD","Beltsville"],["METROPOLITAN CARDIOVASCULAR CONSULTANTS LLC","Daniel Kim","美国","MD","Columbia"],["National Heart Institute","Norman Lepor","美国","CA","Beverly HIlls"],["Capitol Cardiology Associates","Vineet Venugopa","美国","MD","Lanham"],["Flourish Research","Monica Aggarwal","美国","FL","Winter Park"],["Dominion Medical Associates","Richard Jackson.","美国","VA","Richmond"],["Heart Care Associates P C","Kamlesh Dave","美国","VA","Hopewell"],["David Turbay MD PLLC","David Turbay","美国","TX","El Paso"],["Valley Clinical Trials Inc","Fahed Bitar","美国","CA","Covina"],["NexGen Research","Nonso Ezema","美国","OH","Lima"],["Javara Research","Aslam Khan","美国","GA","Fayetteville"],["Zenith Clinical Research","Moises Issa","美国","FL","Hollywood"],["Pharma Tex Research","David Brabham","美国","TX","Amarillo"],["Flourish Research","Sara Collins","美国","MD","Bowie"],["Infinite Clinical Research","Sander Fernandez","美国","FL","Miami"],["Johns Hopkins Univ School of Med","Thorsten Leucker","美国","MD","Baltimore"],["Omega Clinical Research","Tuan-Huy Tran","美国","LA","Metairie"],["Cardiology and Medicine Clinic PA","Joe L Hargrove","美国","AR","Little Rock"],["Sister Life Research Inc","Idania Melo Fernandez","美国","FL","Hialeah"],["SW Family Medicine Associates","Chrisette Dharma","美国","TX","Dallas"],["Overlook Medical Center","Chrisette Dharma","美国","NJ","Summit"],["Sinai Ct for Throm Res and Drug Dev","Paul Gurbel","美国","MD","Baltimore"],["Stern Cardiovascular Foundation Inc","Dharmesh Patel","美国","MS","Southaven"],["Discovery Clinical Trials","Dharmesh Patel","美国","TX","San Antonio"],["MD Medical Research","John Hakim","美国","MD","Oxon Hill"],["Latin Clinical Trial Center Inc","Alex Gonzalez Bossolo","美国","PR","San Juan"],["Research and Cardiovascular Corp","Jose Vazquez-Tanus","美国","PR","Ponce"],["International Research Associates, LLC","Cristian Breton","美国","FL","Orange"],["University of Calif Irvine Med Cntr","Ailin Barseghian El-Farra","美国","CA","Orange"],["Morehouse School Of Medicine","Priscilla Igho-Pemu","美国","GA","Atlanta"],["Robert Wood Johnson Medical School","Tudor Vagaonescu","美国","Atlanta","New Brunswick"],["Elite Clinical Research","Honey East","美国","MS","Jackson"],["Jamaica Hospital Medical Center","David Coven","美国","NY","Richmond Hill"],["VCU HEALTH","Phillip Duncan","美国","VA","Richmond"],["Angel City Research Inc","Felix Sigal","美国","CA","Los Angeles"],["C and A Clinical Trials","Juan Carmona Herrera","美国","FL","Cape Coral"],["Long Beach Clinical Trials","Suzanne Fussel","美国","CA","CA"],["Las Vegas Endocrinology","Quang Nguyen","美国","NV","Henderson"],["Dr Yolanda Figueroa Private Pr","Yolanda Figueroa","美国","PR","Humacao"],["VA Caribbean Healthcare System","Luis Rodriguez-Ospina","美国","PR","San Juan"],["Dallas Heart and Vascular Consultants PA","Imran Afridi","美国","TX","Duncanville"],["TCV Clinical Studies","Edward Stankiewicz","美国","PA","Linwood"],["Plano Primary Care Clinic","Muhammad Farooqi","美国","TX","Plano"],["Stanford Health Care","Abha Khandelwal","美国","CA","Stanford"],["University of Washington","Francis Kim","美国","WA","Seattle"],["New Tampa Health","Francis Kim","美国","FL","Tampa"],["NICRs Research Center","Mallu Reddy","美国","CA","Pomona"],["NICRs Research Center","Hessam Aazami","美国","CA","Canoga Park"],["Epic Clinical Research","Epic Clinical Research","美国","TX","Lewisville"],["Columbus Clinical Services LLC","Sara Llerena","美国","FL","Miami"],["California Medical Research Associates Inc","Jigar Kadakia","美国","CA","Northridge"],["Javara Research","Benjamin Marcum","美国","TX","Stephenville"],["Javara Research","Monique Langston","美国","MD","Annapolis"],["Monroe Research Llc","Assad Mouhaffel","美国","LA","West Monroe"],["Proactive Clinical Research","Maria Coimbra","美国","TX","Edinburg"],["Ascension Saint Agnes Heart Care","Martin Albornoz","美国","MD","MD"],["James A Haley Veterans Hospital","David Whitaker","美国","FL","Tampa"],["A&A Research Group Inc","Rafael Crespo","美国","FL","Miami"],["AA MRC MHS","Khalid Ahmed","美国","MI","Flint"],["Care Access Research","Jimmy Alele","美国","OH","Lima"],["Monroe Biomedical Research","Awawu Igbinadolor","美国","NC","Chicago"],["Synexus Clinical Research US Inc","Joseph Newberg","美国","IL","Chicago"],["The Heart Institute of East Texas","Mohammed Khan","美国","TX","Lufkin"],["Inpatient Research Clinical LLC","Jose Contreras","美国","FL","Florida City"],["Northwest Houston Clinical Research PLLC","Shamaila Aslam","美国","TX","Tomball"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["西安交通大学第一附属医院医学伦理委员会","同意","2026-05-13"]]

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: 34 ； 国际: 366 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 322 ；
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：2025-05-19；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2025-05-28；
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；