一、题目和背景信息
| 登记号 |
CTR20260659 |
| 相关登记号 |
CTR20181567,CTR20210984,CTR20230244 |
| 药物名称 |
植物源重组人血清白蛋白注射液 |
| 药物类型 |
生物制品
|
|
临床申请受理号
|
CXSL1500135 |
| 适应症 |
肝硬化低白蛋白血症（≤30g/L）的治疗 |
| 试验专业题目 |
一项在低白蛋白血症和/或血容量不足需紧急治疗患者中评价重组人白蛋白注射液（水稻）在真实世界中应用的观察性研究 |
| 试验通俗题目 |
一项在低白蛋白血症和/或血容量不足需紧急治疗患者中评价重组人白蛋白注射液（水稻）在真实世界中应用的观察性研究 |
| 试验方案编号 |
HY1001-2025-P4 |
方案最新版本号
|
V2.0 |
| 版本日期: |
2026-01-30 |
方案是否为联合用药 |
否 |
二、申请人信息
| 申请人名称 |
[["武汉禾元生物科技股份有限公司"]] |
| 联系人姓名 |
刘逸斌 |
联系人座机 |
027-59301891-8082 |
联系人手机号 |
18071718725 |
| 联系人Email |
lybin@oryzogen.com |
联系人邮政地址 |
湖北省-武汉市-东湖新技术开发区神墩五路268号 |
联系人邮编 |
430020 |
三、临床试验信息
1、试验目的
在真实世界临床实践中观察重组人白蛋白注射液（水稻）在低白蛋白血症和/或血容量不足需紧急治疗患者中的安全性和有效性。
2、试验设计
| 试验分类 |
安全性和有效性 |
试验分期 |
IV期
|
设计类型 |
单臂试验
|
| 随机化 |
非随机化
|
盲法 |
开放
|
试验范围 |
国内试验
|
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 |
[["年龄≥18岁，男女不限。"],["低白蛋白血症和/或血容量不足需要紧急治疗。"],["同意参加本研究，并由受试者本人或其法定代理人（监护人）签署书面知情同意书。"],["在真实临床实践中，由主治医师决定并计划使用至少一剂人白蛋白注射液。"]]
|
| 排除标准 |
[["已知对本品中的主要成份或任何辅料过敏者。"],["研究者认为存在任何可能显著增加受试者风险，或干扰其参与并完成本研究的医学状况。"],["在本研究入组时，正在参与任何其他药物临床试验者。"]]
|
4、试验分组
| 试验药 |
| 序号 |
名称 |
用法 |
[["中文通用名:重组人白蛋白注射液（水稻）
英文通用名:RecombinantHumanAlbuminInjection(OryzaSativa)
商品名称:奥福民","剂型:注射液
规格:10g/瓶（20%，50mL）
用法用量:治疗剂量和持续时间由主治医生根据患者病情和临床指南决定
用药时程:治疗剂量和持续时间由主治医生根据患者病情和临床指南决定"]]
|
| 对照药 |
| 序号 |
名称 |
用法 |
[["中文通用名:不适用
英文通用名:不适用
商品名称:不适用","剂型:不适用
规格:不适用
用法用量:不适用
用药时程:不适用"]]
|
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 |
[["所有药物不良反应（ADR）的发生率","从开始给药到随访期结束","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 |
[["所有不良事件（AE）的发生率。","从开始给药到随访期结束","安全性指标"],["不同严重程度 AE 的发生率。","从开始给药到随访期结束","安全性指标"],["严重不良事件（SAE）的发生率。","从开始给药到随访期结束","安全性指标"],["特别关注不良事件（AESI）的发生率（包括超敏反应和具有临床意义的QTc间期延长）。","从开始给药到随访期结束","安全性指标"],["导致与重组人白蛋白注射液（水稻）相关的剂量中断、剂量减低、停药或死亡的AE发生率。","给药期间","安全性指标"],["血清白蛋白浓度变化","从开始给药至给药结束","有效性指标"],["容量恢复评估（针对用药原因为“血容量不足”者）","从开始给药到随访期结束","有效性指标"]]
|
四、研究者信息
1、主要研究者信息
| 1 |
姓名 |
南月敏 |
学位 |
医学博士 |
职称 |
主任医师/教授 |
| 电话 |
18533112266 |
Email |
yueminnan@vip.126.com |
邮政地址 |
河北省-石家庄市-自强路139号 |
| 邮编 |
050051 |
单位名称 |
河北医科大学第三医院 |
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 |
[["河北医科大学第三医院","南月敏","中国","河北省","石家庄市"],["福建医科大学孟超肝胆医院","姚履枫","中国","福建省","福州市"],["赣南医科大学第一附属医院","谢军","中国","江西省","赣州市"],["哈尔滨医科大学附属第四医院","于雷","中国","黑龙江省","哈尔滨市"],["湖南医药学院总医院","李勇忠","中国","湖南省","怀化市"],["华中科技大学同济医学院附属协和医院","郑昕","中国","湖北省","武汉市"],["华中科技大学同济医学院附属协和医院","蔺蓉","中国","湖北省","武汉市"],["华中科技大学同济医学院附属同济医院","陈韬","中国","湖北省","武汉市"],["黄冈市中心医院","吴继雄","中国","湖北省","黄冈市"],["惠州市中心人民医院","林占洲","中国","广东省","惠州市"],["吉林大学白求恩第一医院","高沿航","中国","吉林省","长春市"],["吉林省肝胆病医院","陈慧","中国","吉林省","长春市"],["嘉兴市第一医院","邓敏","中国","浙江省","嘉兴市"],["荆州市中心医院","胡勤明/邹传鑫","中国","湖北省","荆州市"],["荆州市第一人民医院","张庆","中国","湖北省","荆州市"],["昆明市第三人民医院","李俊义","中国","云南省","昆明市"],["昆明市第一人民医院","陈钢","中国","云南省","昆明市"],["昆明医科大学第二附属医院","唐映梅","中国","云南省","昆明市"],["南华大学附属南华医院","胡杨","中国","湖南省","衡阳市"],["南华大学第一附属医院","彭忠田/廖爱军","中国","湖南省","衡阳市"],["宁波市第二医院","胡爱荣","中国","浙江省","宁波市"],["宁波市中医院","张婷素/孙常波","中国","浙江省","宁波市"],["瑞安市人民医院","洪亮","中国","浙江省","温州市"],["三峡大学附属仁和医院","戴迟兵","中国","湖北省","宜昌市"],["山东省公共卫生临床中心","张纵","中国","山东省","济南市"],["山西白求恩医院","田德安","中国","山西省","太原市"],["山西医科大学第一医院","张缭云","中国","山西省","太原市"],["绍兴市人民医院","鲁葆春","中国","浙江省","绍兴市"],["十堰太和医院","孟忠吉","中国","湖北省","十堰市"],["温州医科大学附属第一医院","卢明芹","中国","浙江省","温州市"],["武汉大学人民医院","戴锴","中国","湖北省","武汉市"],["武汉大学中南医院","熊勇","中国","湖北省","武汉市"],["武汉市第三医院","田霞","中国","湖北省","武汉市"],["武汉市第一医院","时昭红","中国","湖北省","武汉市"],["武汉市普仁医院","方向明","中国","湖北省","武汉市"],["咸宁市中心医院","朱俊/舒诚荣","中国","湖北省","咸宁市"],["襄阳市第一人民医院","陈伟","中国","湖北省","襄阳市"],["宜昌市中心人民医院","周晓琳/陈萃","中国","湖北省","宜昌市"],["云南省第一人民医院","耿嘉蔚","中国","云南省","昆明市"],["镇江市第三人民医院","葛国洪","中国","江苏省","镇江市"],["郑州大学第一附属医院","余祖江","中国","河南省","郑州市"],["中部战区总医院","徐维田","中国","湖北省","武汉市"],["重庆大学附属三峡医院","安选","中国","重庆市","重庆市"],["遵义医科大学附属医院","罗亚文","中国","贵州省","遵义市"],["中部战区总医院","张波","中国","湖北省","武汉市"],["河北医科大学第二医院","佟飞","中国","河北省","石家庄市"],["华中科技大学同济医学院附属同济医院","邱红","中国","湖北省","武汉市"],["武汉市肺科医院","李铭","中国","湖北省","武汉市"],["黄石市中心医院","张海","中国","湖北省","黄石市"],["荆门市人民医院","李晶晶","中国","湖北省","荆门市"],["国药东风总医院","康助习","中国","湖北省","十堰市"],["武汉科技大学附属天佑医院","罗利琼","中国","湖北省","武汉市"],["湖北航天医院","曹坤","中国","湖北省","孝感市"],["随州市中心医院","张东升","中国","湖北省","随州市"],["襄阳市中心医院","龚伟","中国","湖北省","襄阳市"],["石家庄市人民医院","张燕","中国","河北省","石家庄市"],["武汉市第四医院","李敏","中国","湖北省","武汉市"],["武汉市第五医院","黄颖","中国","湖北省","武汉市"],["鄂州市中心医院","金军","中国","湖北省","鄂州市"],["武汉市金银潭医院","吴文娟","中国","湖北省","武汉市"],["天门市第一人民医院","李永红","中国","湖北省","天门市"],["山西省运城市中心医院","贾莉","中国","山西省","运城市"],["长治医学院附属和平医院","于俊岩","中国","山西省","长治市"],["山西医科大学第二医院","宋翔","中国","山西省","太原市"],["晋中市第一人民医院","张勇进","中国","山西省","晋中市"],["东营市人民医院","陈少平","中国","山东省","东营市"],["胜利油田中心医院","乔鲁军","中国","山东省","东营市"],["山西省中医院","刘丽坤","中国","山西省","太原市"],["淄博市中心医院","张汝敏","中国","山东省","淄博市"],["山西省人民医院","弓清梅","中国","山西省","太原市"],["徐州医科大学附属医院","韩正祥","中国","江苏省","徐州市"],["苏州大学附属第二医院","朱建军","中国","江苏省","苏州市"],["泰州市人民医院","韩高华","中国","江苏省","泰州市"],["苏州大学附属第一医院","陈凯","中国","江苏省","苏州市"],["山东第一医科大学第一附属医院（山东省千佛山医院）","姜志明","中国","山东省","济南市"],["山东第一医科大学附属肿瘤医院（山东省肿瘤医院）","朱栋元","中国","山东省","济南市"],["苏北人民医院","於江泉","中国","江苏省","扬州市"],["青岛山大齐鲁医院（山东大学齐鲁医院（青岛））","曹芳丽","中国","山东省","青岛市"],["滨州医学院烟台附属医院","林思祥","中国","山东省","烟台市"],["淄博市第一医院","丁非","中国","山东省","淄博市"],["淄博市肿瘤医院（淄博市传染病医院）","王克山","中国","山东省","淄博市"],["邢台市人民医院","吴殿超","中国","河北省","邢台市"],["绵阳市第三人民医院","韩建军","中国","四川省","绵阳市"],["三门峡市中心医院","田春桃","中国","河南省","三门峡市"],["海南医科大学第一附属医院","朱永俊","中国","海南省","海口市"],["桂林医科大学第一附属医院","赵燕仪","中国","广西壮族自治区","桂林市"],["宜春人民医院","庄小捷","中国","江西省","宜春市"],["南阳市中心医院","宋展","中国","河南省","南阳市"],["郑州市中心医院","易善永","中国","河南省","郑州市"],["河北北方学院附属第一医院","宋晓","中国","河北省","张家口市"],["河南省直第三人民医院","齐路","中国","河南省","郑州市"],["延安大学咸阳医院","宋海刚","中国","陕西省","咸阳市"],["宜宾市第二人民医院","雷开键","中国","四川省","宜宾市"],["河南大学第一附属医院","王志伟","中国","河南省","开封市"],["广州市第八人民医院","杨右林","中国","广东省","广州市"],["韶关市第一人民医院","李丹","中国","广东省","韶关市"],["中山大学附属第七医院（深圳）","林健","中国","广东省","深圳市"],["广东省农垦中心医院","陈光照","中国","广东省","湛江市"],["湛江中心人民医院","黄庆","中国","广东省","湛江市"],["广州市花都区人民医院","曾晓晖","中国","广东省","广州市"],["山东大学齐鲁第二医院","刘崇忠","中国","山东省","济南市"],["烟台市烟台山医院","周冬梅","中国","山东省","烟台市"],["聊城市人民医院","王宝中","中国","山东省","聊城市"],["华北理工大学附属医院","闫振宇","中国","河北省","唐山市"],["达州市中心医院","吴福道","中国","四川省","达州市"],["内江市第一人民医院","黄思思","中国","四川省","内江市"],["嘉兴市第二医院","范耀华","中国","浙江省","嘉兴市"],["中山大学孙逸仙纪念医院","商昌珍","中国","广东省","广州市"],["深圳市第三人民医院（深圳市传染病医院）","刘虎","中国","广东省","深圳市"],["广东省第二人民医院","刘强","中国","广东省","广州市"],["广州医科大学附属第二医院","温德良","中国","广东省","广州市"],["广州医科大学附属清远医院","宋慧胜","中国","广东省","广州市"],["连州市人民医院","叶水莲","中国","广东省","清远市"],["肇庆市第一人民医院","叶金辉","中国","广东省","肇庆市"],["中山大学附属第五医院","张慧涛","中国","广东省","珠海市"],["南阳市第一人民医院","张震","中国","河南省","南阳市"],["安阳市人民医院","王永亮","中国","河南省","安阳市"],["许昌市人民医院","王晓辉","中国","河南省","许昌市"],["濮阳市人民医院","周红林","中国","河南省","濮阳市"],["周口市中心医院","徐克友","中国","河南省","周口市"],["鹤壁市人民医院","张国政","中国","河南省","鹤壁市"],["驻马店市中心医院","杨光华","中国","河南省","驻马店市"],["临汾市中心医院","赵学红","中国","山西省","临汾市"],["山东第一医科大学第二附属医院","刘海燕","中国","山东省","泰安市"],["泰安市中心医院","魏林","中国","山东省","泰安市"],["山东省立第三医院","李锴男","中国","山东省","济南市"],["山东中医药大学第二附属医院","崔兴","中国","山东省","济南市"],["江门市中心医院","余更生","中国","广东省","江门市"],["广州市中西医结合医院","钟灼","中国","广东省","广州市"],["康复大学青岛中心医院（青岛市中心医院）","徐艳霞","中国","山东省","青岛市"]]
五、伦理委员会信息
| 序号 |
名称 |
审查结论 |
批准日期/备案日期 |
[["河北医科大学第三医院医学伦理委员会","同意","2026-02-05"]]
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: 登记人暂未填写该信息； |
| 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； |
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； |
| 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； |
