长沙SHR-2004注射液III期临床试验-全膝关节置换术患者使用SHR-2004注射液预防静脉血栓栓塞症的III期临床研究

登记号	CTR20250464	试验状态	进行中
申请人联系人	聂状	首次公示信息日期	2025-02-12
申请人名称	北京盛迪医药有限公司/ 苏州盛迪亚生物医药有限公司

登记号	CTR20250464
相关登记号	暂无
药物名称	SHR-2004注射液
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	预防动静脉血栓
试验专业题目	评价择期全膝关节置换术患者使用SHR-2004注射液预防静脉血栓栓塞症的有效性和安全性的多中心、随机、双盲、阳性对照III期临床研究
试验通俗题目	全膝关节置换术患者使用SHR-2004注射液预防静脉血栓栓塞症的III期临床研究
试验方案编号	SHR-2004-301	方案最新版本号	2.0
版本日期:	2025-01-10	方案是否为联合用药	否

申请人名称	[["北京盛迪医药有限公司"],["苏州盛迪亚生物医药有限公司"]]
联系人姓名	聂状	联系人座机	0518-82342973	联系人手机号
联系人Email	zhuang.nie@hengrui.com	联系人邮政地址	江苏省-连云港市-经济技术开发区昆仑山路7号	联系人邮编	222047

主要目的：评价行择期全膝关节置换术的患者使用SHR-2004注射液在治疗期间预防术后总静脉血栓栓塞症的有效性。 次要目的：评价行择期TKA患者使用SHR-2004注射液的安全性、药代动力学特征、药效动力学特征、免疫原性等。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国内试验

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	[["自愿签署知情同意书。"],["拟行择期TKA的患者。"],["签署知情同意书当日年龄≥18周岁且<80周岁的男性或女性。"]]
排除标准	[["经研究者判断预期无法接受双下肢静脉CT血管成像检查者。"],["筛选前1年内患有恶性肿瘤(经根治性治疗的非黑色素瘤皮肤癌或宫颈原位癌除外)。"],["可能增加出血风险的病史或研究者认为有增加出血风险的任何情况。"],["筛选时患有不稳定的或严重的肝脏、肾脏、心血管、精神、神经、内分泌、血液学等疾病，研究者判定参与研究会使受试者处于不可接受的风险中。"],["任何其他有临床意义的异常实验室值、且经研究者判定不适合入组。"],["有吸毒史或药物滥用史者。"],["妊娠或哺乳期的女性。"]]

试验药	[["中文通用名:SHR-2004注射液 英文通用名:SHR-2004injection 商品名称:NA","剂型:注射液 规格:1.0ml:0.12g/瓶 用法用量:皮下注射，用药日用药一次，120mg；或静脉滴注，用药日用药一次，90mg。 用药时程:共用药1次。"]] 序号 名称 用法
对照药	[["中文通用名:SHR-2004安慰剂 英文通用名:SHR-2004placebo 商品名称:NA","剂型:注射液 规格:1.0ml/瓶 用法用量:皮下注射，用药日用药一次，1.0ml；或静脉滴注，用药日用药一次，0.75ml。 用药时程:共用药1次。"],["中文通用名:依诺肝素钠注射液 英文通用名:Enoxaparinsodiuminjection 商品名称:百力佳","剂型:注射液 规格:0.4ml:4000AxaIU/支 用法用量:皮下注射，每日一次，每次40mg。 用药时程:共用药12-14次。"],["中文通用名:依诺肝素钠安慰剂 英文通用名:Enoxaparinsodiuminjectionplacebo 商品名称:NA","剂型:注射液 规格:0.4ml/支 用法用量:皮下注射，每日一次，每次40mg。 用药时程:共用药12-14次。"]] 序号 名称 用法

主要终点指标及评价时间	[["VTE和全因死亡的发生率。","首次用药至治疗期结束。","有效性指标"],["符合大出血和临床相关非大出血事件的复合终点发生率。","首次用药至治疗期结束。","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	[["主要疗效终点的各组分事件发生率。","首次用药至治疗期结束。","有效性指标"],["重大VTE和全因死亡的发生率。","首次用药至随访结束。","有效性指标"],["总VTE和全因死亡的发生率及各组分事件发生率。","首次用药至治疗期结束。","有效性指标"],["重大VTE和全因死亡的发生率。","首次用药至随访结束。","有效性指标"],["主要安全性终点各组分事件发生率。","首次用药至治疗期结束。","安全性指标"],["任何出血事件的发生率。","首次用药至随访结束。","安全性指标"],["符合大出血和临床相关非大出血事件的复合终点发生率。","首次用药至随访结束。","安全性指标"],["不良事件的发生率及严重程度。","首次用药至随访结束。","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	雷光华	学位	医学博士	职称	教授
	电话	0731-89753999	Email	lei_guanghua@csu.edu.cn	邮政地址	湖南省-长沙市-开福区湘雅路87号
	邮编	410008	单位名称	中南大学湘雅医院

[["中南大学湘雅医院","雷光华","中国","湖南省","长沙市"],["中国人民解放军总医院第四医学中心","唐佩福","中国","北京市","北京市"],["安徽医科大学第二附属医院","姚运峰","中国","安徽省","合肥市"],["北京大学深圳医院","王德利","中国","广东省","深圳市"],["北京积水潭医院贵州医院","张骏","中国","贵州省","贵阳市"],["北京清华长庚医院","蔡谞","中国","北京市","北京市"],["北京医院","薛庆云","中国","北京市","北京市"],["成都市第五人民医院","刑叔星","中国","四川省","成都市"],["常德市第一人民医院","林谦","中国","湖南省","常德市"],["赤峰市医院","孙智文","中国","内蒙古自治区","赤峰市"],["重庆医科大学附属第二医院","聂茂","中国","重庆市","重庆市"],["常州市第二人民医院","徐南伟","中国","江苏省","常州市"],["常州市第一人民医院","王益民","中国","江苏省","常州市"],["郴州市第一人民医院","肖勋刚","中国","湖南省","郴州市"],["池州市人民医院","谢贵杰","中国","安徽省","池州市"],["大连大学附属中山医院","王铁男","中国","辽宁省","大连市"],["复旦大学附属中山医院","阎作勤","中国","上海市","上海市"],["福建医科大学附属第一医院","张文明","中国","福建省","福州市"],["福建医科大学附属协和医院","陈敏","中国","福建省","福州市"],["广东省人民医院","郑秋坚","中国","广东省","广州市"],["甘肃省人民医院","郭洪章","中国","甘肃省","兰州市"],["赣州市人民医院","肖军","中国","江西省","赣州市"],["广州医科大学附属第一医院","卢伟杰","中国","广东省","广州市"],["贵州医科大学附属医院","李江伟","中国","贵州省","贵阳市"],["广州中医药大学第一附属医院","王海彬","中国","广东省","广州市"],["淮北矿工总医院","陈亮","中国","安徽省","淮北市"],["河北省沧州中西医结合医院","李晓明","中国","河北省","沧州市"],["河北省人民医院","李文毅","中国","河北省","石家庄市"],["河北医科大学第三医院","董江涛","中国","河北省","石家庄市"],["河北医科大学第一医院","刘国彬","中国","河北省","石家庄市"],["合肥市第二人民医院","储建军","中国","安徽省","合肥市"],["合肥市第一人民医院","宁仁德","中国","安徽省","合肥市"],["核工业总医院（苏州大学附属第二医院）","周晓中","中国","江苏省","苏州市"],["河南大学第一附属医院","杨广杰","中国","河南省","开封市"],["吉林大学第一医院","齐欣","中国","吉林省","长春市"],["吉林大学第一医院梅河医院（梅河口市中心医院）","宋洪光","中国","吉林省","通化市"],["江门市中心医院","邬黎平","中国","广东省","江门市"],["暨南大学附属第一医院（广州华侨医院）","侯辉歌","中国","广东省","广州市"],["济南市中心医院","郭舒亚","中国","山东省","济南市"],["济宁医学院附属医院","陈国武","中国","山东省","济宁市"],["江西省人民医院（南昌医学院第一附属医院）","陈钢","中国","江西省","南昌市"],["江阴市人民医院","姜雪峰","中国","江苏省","无锡市"],["昆明医科大学第一附属医院","王兵","中国","云南省","昆明市"],["喀什地区第一人民医院","阿力木·克热木","中国","新疆维吾尔自治区","喀什地区"],["聊城市人民医院","苑振峰","中国","山东省","聊城市"],["丽水市中心医院","何登伟","中国","浙江省","丽水市"],["连云港市第一人民医院","秦入结","中国","江苏省","连云港市"],["柳州市人民医院","彭伟秋","中国","广西壮族自治区","柳州市"],["宁波大学附属第一医院","朱迎春","中国","浙江省","宁波市"],["南昌大学第二附属医院","程细高","中国","江西省","南昌市"],["南方医科大学第三附属医院、广东省骨科医院","曾春","中国","广东省","广州市"],["内蒙古自治区人民医院","徐永胜","中国","内蒙古自治区","呼和浩特市"],["南通大学附属医院","刘璠","中国","江苏省","南通市"],["南阳市第二人民医院","尚立林","中国","河南省","安阳市"],["濮阳市人民医院","马方南","中国","河南省","濮阳市"],["濮阳油田总医院（濮阳市油田总医院）","刘涛","中国","河南省","濮阳市"],["攀枝花市中心医院","钟凤林","中国","四川省","攀枝花市"],["齐齐哈尔市第一医院","林林","中国","黑龙江省","齐齐哈尔市"],["苏北人民医院","颜连启","中国","江苏省","扬州市"],["四川大学华西医院","康鹏德","中国","四川省","成都市"],["山东大学第二医院","刘胜厚","中国","山东省","济南市"],["山东大学齐鲁医院","刘培来","中国","山东省","济南市"],["山东第一医科大学第一附属医院（山东省千佛山医院）","吴剑波","中国","山东省","济南市"],["首都医科大学附属北京积水潭医院","徐辉","中国","北京市","北京市"],["首都医科大学附属北京潞河医院","刘亮","中国","北京市","北京市"],["首都医科大学宣武医院","鲁世保","中国","北京市","北京市"],["上海市东方医院","尹峰","中国","上海市","上海市"],["上海市浦东医院","姜新华","中国","上海市","上海市"],["三门峡市中心医院","丁韶龙","中国","河南省","三门峡市"],["上饶市人民医院","吴国保","中国","江西省","上饶市"],["汕头大学医学院第一附属医院","胡军","中国","广东省","汕头市"],["绍兴第二医院医共体总院（绍兴第二医院）","马一鸣","中国","浙江省","绍兴市"],["陕西省人民医院","刘时璋","中国","陕西省","西安市"],["绍兴市人民医院","李宏斌","中国","浙江省","绍兴市"],["山西医科大学第二医院","冯毅","中国","山西省","太原市"],["沈阳市骨科医院","柳椰","中国","辽宁省","沈阳市"],["沈阳医学院附属中心医院","赵伟","中国","辽宁省","沈阳市"],["深圳市人民医院","李广恒","中国","广东省","深圳市"],["天津市天津医院","刘军","中国","天津市","天津市"],["天津医科大学总医院","宁广智","中国","天津市","天津市"],["潍坊市人民医院","王炳武","中国","山东省","潍坊市"],["无锡市中医医院","张亚峰","中国","江苏省","无锡市"],["温州医科大学附属第二医院","陈华","中国","浙江省","温州市"],["温州医科大学附属第一医院","陈雷","中国","浙江省","温州市"],["西安市红会医院","马建兵","中国","陕西省","西安市"],["新疆维吾尔自治区人民医院","王利","中国","新疆维吾尔自治区","乌鲁木齐市"],["徐州医科大学附属医院","周冰","中国","江苏省","徐州市"],["宜昌市中心人民医院（伍家院区）","寿康全","中国","湖北省","宜昌市"],["宜昌市中心人民医院（西陵院区）","梁杰","中国","湖北省","宜昌市"],["运城市中心医院","周志康","中国","山西省","运城市"],["玉林市中西医结合骨科医院","梁雄伟","中国","广西壮族自治区","玉林市"],["云南省滇南中心医院（红河哈尼族彝族自治州第一人民医院)","曾德妙","中国","云南省","红河哈尼族彝族自治州"],["阳泉煤业（集团）有限责任公司总医院","王汝江","中国","山西省","阳泉市"],["烟台毓璜顶医院","王光达","中国","山东省","烟台市"],["中国人民解放军联勤保障部队第九六〇医院","于秀淳","中国","山东省","济南市"],["中国医科大学附属第一医院","朱悦","中国","辽宁省","沈阳市"],["中国医科大学附属盛京医院","商冠宁","中国","辽宁省","沈阳市"],["浙江省人民医院毕节医院","张骏","中国","贵州省","毕节市"],["中南大学湘雅二医院","黄添隆","中国","湖南省","长沙市"],["中南大学湘雅三医院","吴松","中国","湖南省","长沙市"],["遵义医科大学附属医院","彭笳宸","中国","贵州省","遵义市"],["东南大学附属中大医院","陆军","中国","江苏省","南京市"],["铜陵市人民医院","夏良政","中国","安徽省","铜陵市"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["中南大学湘雅医院临床医学伦理委员会","同意","2024-09-24"],["中南大学湘雅医院临床医学伦理委员会","同意","2025-01-21"]]

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: 1167 ；
已入组人数	国内: 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；

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；
第一例受试者入组日期	国内：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；