一、题目和背景信息
| 登记号 |
CTR20254000 |
| 相关登记号 |
暂无
|
| 药物名称 |
PF-07868489 |
| 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 |
肺动脉高压 |
| 试验专业题目 |
一项在成人肺动脉高压研究参与者中评价 PF-07868489 给药的安全性和疗效的 II 期、开放性扩展研究 |
| 试验通俗题目 |
一项在既往参加过 PF-07868489 临床试验的肺动脉高压研究参与者中进行的开放性扩展研究 |
| 试验方案编号 |
C5001004 |
方案最新版本号
|
最终方案 |
| 版本日期: |
2025-05-21 |
方案是否为联合用药 |
否 |
二、申请人信息
| 申请人名称 |
[["Pfizer Inc."],["辉瑞（中国）研究开发有限公司"],["Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC"]] |
| 联系人姓名 |
王进 |
联系人座机 |
021-28935242 |
联系人手机号 |
|
| 联系人Email |
jin.wang@pfizer.com |
联系人邮政地址 |
上海市-上海市-静安区南京西路1168号中信泰富广场36层 |
联系人邮编 |
200041 |
三、临床试验信息
1、试验目的
评估 PAH 研究参与者接受 PF-07868489 SC 重复给药的长期安全性、耐受性和有效性
2、试验设计
| 试验分类 |
安全性和有效性 |
试验分期 |
II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
无上限
(最大年龄) |
| 性别 |
男+女
|
| 健康受试者 |
无
|
| 入选标准 |
[["资格确认（前期）研究筛选时年龄 ≥ 18 岁，且在资格确认研究中完成规定的治疗周期，并在该研究结束时完成其它相关评估。"],["愿意并且能够遵从所有计划访视、治疗计划、实验室检查、生活方式注意事项和其他研究程序的研究参与者。"]]
|
| 排除标准 |
[["在资格确认研究期间出现 PAH 临床恶化和因 PAH 恶化住院治疗的研究参与者。"],["计划进行任何组织或身体部位（移植）替换手术。"],["在资格确认研究中，研究参与者存在仍在进行中的严重健康问题，研究者认为该研究参与者不满足参与研究的条件。"],["既往或当前确诊的肝肺综合征。"],["目前使用 GLP-1 激动剂。"]]
|
4、试验分组
| 试验药 |
| 序号 |
名称 |
用法 |
[["中文通用名:PF-07868489
英文通用名:PF-07868489
商品名称:NA","剂型:注射剂
规格:Amg/ml
用法用量:每4周一次，皮下注射给药
用药时程:111周"]]
|
| 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 |
[["经治疗出现的 AE 和 SAE 的研究参与研究者人数","整个试验期间","安全性指标"],["临床实验室检查值较基线有变化的研究参与者人数","整个试验期间","安全性指标"],["生命体征较基线有变化的研究参与者人数","整个试验期间","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 |
[["心电图（ECG）参数较基线有变化的研究参与者人数","整个试验期间","安全性指标"],["NT-pro-BNP 较基线有变化的研究参与者人数","整个试验期间","有效性指标+安全性指标"],["最低血药浓度（如果数据允许）","整个试验期间","有效性指标+安全性指标"],["抗药抗体（ADA ）的发生率","整个试验期间","有效性指标+安全性指标"]]
|
四、研究者信息
1、主要研究者信息
| 1 |
姓名 |
荆志成 |
学位 |
医学博士 |
职称 |
主任医师 |
| 电话 |
020-83827812 |
Email |
jingzhicheng@gdph.org.cn |
邮政地址 |
广东省-广州市-中山二路106号 |
| 邮编 |
510000 |
单位名称 |
广东省人民医院 |
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 |
[["广东省人民医院","荆志成","中国","广东省","广州市"],["广东省人民医院","姚桦","中国","广东省","广州市"],["中南大学湘雅二医院","李江","中国","湖南省","长沙市"],["上海市肺科医院","王岚","中国","上海市","上海市"],["东南大学附属中大医院","章锐锋","中国","江苏省","南京市"],["Royal Prince Alfred Hospital","Lau, Edmund Man Tai","澳大利亚","NEW SOUTH WALES","Camperdown"],["John Hunter Hospital, NSW Health","Reeves, Glenn Edward","澳大利亚","NEW SOUTH WALES","NEW LAMBTON"],["University of Colorado Anschutz Medical Campus","Badesch, David Brian","美国","COLORADO","Aurora"],["UKGM Gieben/Marburg","Ghofrani, Ardeschir","德国","HESSEN","Giessen"],["UNC Health - Eastowne Medical Office","Ford, Hubert James","美国","NORTH CAROLINA","Chapel Hill"],["University of California Davis Health","Sood, Namita","美国","CALIFORNIA","Sacramento"],["Norton Pulmonary Specialists","McConnell, John Wesley","美国","KENTUCKY","Louisville"],["Wesley Research Institute","Feenstra, John Fitzgerald Eelke","澳大利亚","QUEENSLAND","Auchenflower"],["Hospital Universitario 12 de Octubre","Escribano Subias, Pilar","西班牙","MADRID, COMUNIDAD DE","Madrid"],["Université Libre de Bruxelles - Hopital Erasme","Vachiery, Jean-Luc","比利时","BRUXELLES-CAPITALE, RéGION DE","Anderlecht"],["University of California, Irvine (UCI) Health - UC Irvine Medical Center","Yaghmour, Bassam","美国","CALIFORNIA","orange"],["General University Hospital in Prague","Jansa, Pavel","捷克","PRAHA 2","Praha 2 - Nove Mesto"],["Hospital Universitario La Paz","Alcolea Batres, Sergio","西班牙","MADRID","Madrid"],["Institut Klinicke a Experimentalni Mediciny","Al-hiti, Hikmet","捷克","NA","Praha 4"],["National Hospital Organization Okayama Medical Center","Matsubara, Hiromi","日本","OKAYAMA","Okayama City"],["Kobe University Hospital","Taniguchi, Yu","日本","HYOGO","Kobe"],["Hammersmith Hospital","Howard, Luke","英国","ENGLAND","London"],["Royal Brompton Hospital","Wort, Stephen John","英国","LONDON, CITY OF","London"],["Hospital Marqués de Valdecilla","Cifrian, Jose Manuel","西班牙","CANTABRIA","Santander"],["Mount Sinai Medical Center","Trivieri, Maria Giovanna","美国","NY","New York"],["Universitaetsklinikum Carl Gustav Carus Dresden","Halank, Michael","德国","SACHSEN","Dresden"],["CHRU de Brest","Tromeur, Cecile","法国","BRETAGNE","Brest"],["CHU Saint Etienne","Bertoletti, Laurent","法国","LOIRE","Saint-Priest-en-Jarez"],["Thoraxklinik-Heidelberg gGmbH","Gruenig, Ekkehard","德国","BADEN-WüRTTEMBERG","Heidelberg"],["ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione","Vitulo, Patrizio","意大利","PALERMO","Palermo"],["Fondazione IRCCS Policlinico San Matteo","Ghio, Stefano","意大利","LOMBARDIAV","Pavia"],["Fondazione IRCCS San Gerardo dei Tintori","Paciocco, Giuseppe","意大利","MONZA E BRIANZA","Monza"],["UZ Leuven","Delcroix, Marion","比利时","VLAAMS-BRABANT","Leuven"],["Universitaetsmedizin Greifswald","Ewert, Ralf","德国","NA","Greifswald"],["Tohoku University Hospital","Yaoita, Nobuhiro","日本","MIYAGI","Sendai"],["Royal Free Hospital","Coghlan, John Gerry","英国","NA","London"],["Universitaetsklinikum Regensburg","Stadler, Stefan","德国","NA","Regensburg"],["Golden Jubilee National Hospital","church, colin","英国","NA","Clydebank"],["Rhode Island Hospital","Klinger, James Raymond","美国","RHODE ISLAND","Providence"],["Gachon University Gil Medical Center","Chung, Wook-Jin","韩国","INCHEON-GWANGYEOKSI [INCHEON]","Incheon"],["Severance Hospital, Yonsei University Health System","Chang, Hyuk-Jae","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Seoul National University Hospital","Kim, Hyung-Kwan","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Samsung Medical Center","Chang, Sung-A","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["UCSF Helen Diller Medical Center at Parnassus Heights","Barnett, Christopher","美国","CALIFORNIA","San Francisco"],["University of Alberta Hospital","Michelakis, Evangelos","加拿大","ALBERTA","Edmonton"],["Victoria Hospital & Children's Hospital – London Health Sciences Centre","Mehta, Sanjay","加拿大","ONTARIO","London"],["CHU GRENOBLE ALPES","Degano, Bruno","法国","NA","La Tronche"],["Medical University of South Carolina","Argula, Rahul","美国","SOUTH CAROLINA","Charleston"],["Yokohama City University Hospital","Hibi, Kiyoshi","日本","KANAGAWA","Yokohama"],["St.Marianna University Hospital","Tanabe, Yasuhiro","日本","KANAGAWA","Kawasaki"],["University General Hospital Attikon","Tsagkaris, Iraklis","希腊","ATTIKI","Athens"],["Aristotle University of Thessaloniki","Giannakoulas, Georgios","希腊","NA","Thessaloniki"],["ONASSIS Cardiac Surgery Center","TSIAPRAS, DIMITRIOS","希腊","NA","Athens"]]
五、伦理委员会信息
| 序号 |
名称 |
审查结论 |
批准日期/备案日期 |
[["广东省人民医院伦理审查委员会","同意","2025-07-25"]]
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: 36 ； |
| 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； |
