一、题目和背景信息
| 登记号 |
CTR20260186 |
| 相关登记号 |
暂无
|
| 药物名称 |
DII235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Lp(a)升高患者的心血管风险 |
| 试验专业题目 |
一项评价DII235在脂蛋白(a) 升高成人中的有效性、安全性和耐受性的多中心、随机、双盲、安慰剂对照、平行组、剂量探索研究 |
| 试验通俗题目 |
一项在脂蛋白(a) 升高的成人中的研究 |
| 试验方案编号 |
CDII235A12201 |
方案最新版本号
|
v00 |
| 版本日期: |
2025-07-10 |
方案是否为联合用药 |
否 |
二、申请人信息
| 申请人名称 |
[["诺华（中国）生物医学研究有限公司"],["凯莱英生命科学技术（天津）有限公司"]] |
| 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号中国人寿金融中心3层 |
联系人邮编 |
100022 |
三、临床试验信息
1、试验目的
本研究的目的是考察DII235在脂蛋白(a)（Lp(a)）升高参与者中的有效性、安全性和耐受性以及剂量-应答关系。
2、试验设计
| 试验分类 |
安全性和有效性 |
试验分期 |
其他
|
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
|
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 |
[["在参与研究之前必须获得签署的知情同意书。"],["筛选访视时年龄为18至80岁（含）的男性或女性。"],["筛选访视时参与者中心实验室测得Lp(a) ≥ 150 nmol/L。"],["存在动脉粥样硬化性心血管疾病（ASCVD）和/或2型糖尿病（T2DM）。"]]
|
| 排除标准 |
[["严重肾功能不全"],["肝功能不全"],["过去5年内患有恶性肿瘤"],["使用方案中规定禁用的研究药物"],["筛选时存在或既往存在可能影响受试者安全性、或干扰参加或完成研究、或数据解读的基础疾病或手术、身体、医学、精神的相关状况"]]
|
4、试验分组
| 试验药 |
| 序号 |
名称 |
用法 |
[["中文通用名:DII235注射液
英文通用名:DII235solutionforinjection
商品名称:NA","剂型:注射液
规格:不公示
用法用量:皮下注射
用药时程:多次给药"]]
|
| 对照药 |
| 序号 |
名称 |
用法 |
[["中文通用名:安慰剂
英文通用名:placebo
商品名称:NA","剂型:注射液
规格:不公示
用法用量:皮下注射
用药时程:多次给药"]]
|
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 |
[["第60天和第180天之间较基线的时间平均百分比变化","基线至60天和180天","有效性指标"],["DII235第2次给药和安慰剂之间第60天和第360天之间测量的Lp（a）较基线的时间平均百分比变化的差异","基线至60天和360天","有效性指标"],["第60天和第360天之间测量的DII235剂量4和安慰剂之间Lp（a）较基线的时间平均百分比变化的差异","基线至60天和360天","有效性指标"]]
|
| 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 |
[["第60天和第360天之间测量的DII235第1次给药、第3次给药和安慰剂与安慰剂之间Lp（a）较基线的时间平均百分比变化的差异","基线至60天和360天","有效性指标"],["第240天和第360天之间测量的DII235剂量与安慰剂之间Lp（a）较基线的时间平均百分比变化的差异","基线至240天和360天","有效性指标"],["在第180天和第360天达到Lp（a）< 125 nmol/L的受试者比例方面，DII235剂量与安慰剂之间的差异","180天和360天","有效性指标"],["在第180天和第360天达到Lp（a） < 75 nmol/L的受试者比例方面，DII235剂量与安慰剂之间的差异","180天和360天","有效性指标"]]
|
四、研究者信息
1、主要研究者信息
| 1 |
姓名 |
李建平 |
学位 |
博士后 |
职称 |
正高级 |
| 电话 |
18840728905 |
Email |
13521531013@163.com |
邮政地址 |
北京市-北京市-西城区西什库大街7号北京大学第一医院 |
| 邮编 |
100034 |
单位名称 |
北京大学第一医院 |
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 |
[["北京大学第一医院","李建平","中国","北京市","北京市"],["温州医科大学附属第一医院","黄周青","中国","浙江省","温州市"],["辽宁省人民医院","刘莹","中国","辽宁省","沈阳市"],["洛阳市第三人民医院","李立鹏","中国","河南省","洛阳市"],["Universitaets Herzzentrum","Christian Valina","Germany","Bad Krozingen","Bad Krozingen"],["Velocity Clinical Research GmbH","Isabelle Schenkenberger","Germany","Berlin","Berlin"],["St Johannes Hospital","Helge Moellmann","Germany","Dortmund","Dortmund"],["UHZ Klinische Forschung","Heiner Saueressig","Germany","Essen","Essen"],["Universitaetsklinikum Essen","Amir-Abbas Mahabadi","Germany","Nordrhein-Westfalen","Nordrhein-Westfalen"],["ClinPhenomics CVC GmbH","Martin Duersch","Germany","Frankfurt","Frankfurt"],["Universitaetsklinikum Magdeburg","Katrin Borucki","Germany","Saxony-Anhalt","Magdeburg"],["Kardiologische Praxis Dr Wilke","Andreas Wilke","Germany","Papenburg","Papenburg"],["Universitaetsmedizin Charite","Elisabeth Steinhagen-Thiessen","Germany","Berlin","Berlin"],["Universitaetsklinikum Rostock","Elisabeth Steinhagen-Thiessen","Germany","Rostock","Rostock"],["Klinik am See","Heinz Voeller","Germany","Ruedersdorf","Ruedersdorf"],["Josephs-Hospital Warendorf","Norbert Wistorf","Germany","Warendorf","Warendorf"],["Universitaetsklinikum Dresden","Ulrike Schatz","Germany","Dresden","Dresden"],["Universitaetsklinikum Muenchen LMU","Stefan Kaeaeb","Germany","Bayern","Bayern"],["Diabetesforschung Muenster","Ludger Rose","Germany","Muenster","Muenster"],["Muenster","Stephan Schirmer","Germany","Rheinland-Pfalz","Kaiserslautern"],["Hausarztzentrum Butendorf","Christa Dohmann-Hoeren","Germany","Gladbeck","Gladbeck"],["Herz u Diabeteszentrum NRW","Florian Willecke","Germany","Bad Oeynhausen","Bad Oeynhausen"],["Diamedikum Potsdam MVZ","Michael Haase","Germany","Brandenburg","Potsdam"],["Heishinkai ToCROM Clinic","Osamu Matsuoka","Japan","Tokyo","Shinjuku ku"],["Heishinkai ToCROM Clinic","Satoshi Inoue","Japan","Osaka","Suita-city"],["Kagawa Prefectural Central Hospital","Masayuki Doi","Japan","Kagawa","Takamatsu-city"],["Miyazaki Medical Association Hosp","Yoshisato Shibata","Japan","Miyazaki","Miyhazaki"],["Chiba-Nishi General Hospital","Takehiko Kuramochi","Japan","Chiba","Matsudo-city"],["Rakuwakai Otowa Hospital","Hirokazu Yokoi","Japan","Kyoto","Kyoto"],["North Tyneside General Hospital","David Ripley","United Kingdom","Tyne and Wear","Tyne and Wear"],["Cardiff Medicentre","Soha Zouwail","United Kingdom","Cardiff","Cardiff"],["Bristol Royal Infirmary","Kofi Antwi","United Kingdom","Bristol","Bristol"],["Royal Lancaster Infirmary","Mohamed Nabil Kam Elnaggar","United Kingdom","Lancaster","Lancaster"],["Anderson Medical Research","Felton Anderson","United States","MD","Fort Washington"],["Inpatient Research Clinical LLC","Alexis Gutierrez","United States","FL","Miami Lakes"],["Dominion Medical Associates","Richard Jackson","United States","VA","Richmond"],["AB Clinical Trials","Atoya Adams","United States","NV","Las Vegas"],["Capitol Cardiology Associates","Vineet Venugopal","United States","MD","Lanham"],["Jacksonville Center for Clinical Research","Michael Koren","United States","FL","Jacksonville"],["Progressive Clinical Research","Joshua Oaks","United States","UT","Bountiful"],["Cardiology Partners Clinical Research Institute","Duccio Baldari","United States","FL","Wellington"],["METROPOLITAN CARDIOVASCULAR CONSULTANTS LLC","Ayim Akyea-Djamson","United States","MD","Beltsville"],["Zenith Clinical Research","Moises Issa","United States","FL","Hollywood"],["Angiocardiac Care of Texas PA","Amin Karim","United States","TX","Houston"],["Northwest Houston Clinical Research PLLC","Shamaila Aslam","United States","TX","Tomball"],["SEC Clinical Research","William Doty","United States","FL","Pensacola"],["National Heart Institute","Norman Lepor","United States","CA","Beverly Hills"],["AA Medical Research Center","Ahmed A Arif","United States","MI","Flint"],["Dallas Heart and Vascular Consultants PA","Imran Afridi","United States","TX","Duncanville"],["CV Ins of the South","Wade May","United States","LA","Lafayette"],["Dallas Heart and Vascular Consultants PA","Syed Humayun Naqvi","United States","TX","Houston"],["Affinity Health Corp","Saifullah Nasir","United States","IL","Park Ridge"],["Alliance for Multispecialty Resrch","Jerry Punch","United States","TN","Knoxville"],["Clinical Trials of Texas","Douglas Denham","United States","TX","San Antonio"],["Flourish Res Acq LLC North Miami","Rimsky Denis","United States","FL","Miami"],["Excel Medical Clinical Trials LLC","Rasha Youssef","United States","FL","Boca Raton"],["Trinity Health Michigan Heart","Ahmad Mizyed","United States","MI","Ypsilanti"],["Heart Center Research Llc","Vernon Hunter","United States","AL","Huntsville"],["Parkway Medical Center","James Sullivan","United States","AL","Birmingham"],["TCV Clinical Studies","Edward Stankiewicz","United States","PA","Linwood"],["Cardiology and Medicine Clinic PA","Joe L Hargrove","United States","AR","Little Rock"],["Alliance Clinical","Hessam Aazami","United States","CA","West Hills"],["Inpatient Research Clinical LLC","Jose Contreras","United States","FL","Florida City"],["Atlanta Heart Specialists LLC","David Suh","United States","GA","Tucker"],["Ocala Cardiovascular Research","Lan Luo","United States","FL","Ocala"],["Cardiology Consultants of Philadelphia","Paul Grena","United States","PA","Tucker"],["Apex Cardiology Research Associates of Jackson","Mohsin Alhaddad","United States","TN","Yardley"],["K and R Research LLC","Parminder Singh","United States","OH","Jackson"],["MultiCare Ins Research Innovation","Vinay Malhotra","United States","WA","Puyallup"],["Novant Health Heart Vas Inst","Anish Vani","United States","NC","Charlotte"],["Foothill Cardiology","Fahed Bitar","United States","CA","Covina"],["Monroe Research Llc","Assad Mouhaffel","United States","LA","West Monroe"]]
五、伦理委员会信息
| 序号 |
名称 |
审查结论 |
批准日期/备案日期 |
[["北京大学第一医院生物医学研究伦理委员会","同意","2025-12-08"]]
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: 12 ；
国际: 227 ； |
| 已入组人数 |
国内: 登记人暂未填写该信息；
国际: 1 ； |
| 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：2025-12-02； |
| 第一例受试者入组日期 |
国内：登记人暂未填写该信息；
国际：2025-12-16； |
|
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； |
