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汇聚全球临床试验数据，覆盖中国、美国、欧盟、日本等主要国家/地区，涵盖包括试验登记号、试验药物、适应症、研发阶段、招募状态、试验设计、方案摘要、试验结果及试验机构等关键信息，每日动态更新，已收录登记信息超100万项。
1. 中国临床试验
1.1 概述
本库完整整合药品审评中心（CDE）、中国临床试验注册中心及国际传统医学临床试验注册平台（ICTMP）三大官方平台登记的全部临床试验信息，涵盖试验设计、招募详情、研究者信息、试验药物、适应症、研发阶段、试验状态及结果摘要等核心内容。每日动态更新，数据总量逾14万条。
1.2 数据结构与样例
JSON格式
{
"登记号": "CTR20252702",
"相关登记号":[""],
"是否联合用药":"否",
"药物名称":"多替拉韦恩曲他滨丙酚替诺福韦片",
"规范名称":"多替拉韦恩曲他滨丙酚替诺福韦片",
"曾用名":"",
"药品类型":"化学药物",
"药物类型":"化学药",
"创新类型":"其他",
"适应症":"多替拉韦恩曲他滨丙酚替诺福韦是由多替拉韦(整合酶链转移抑制剂[INSTI])、恩曲他滨(FTC)和丙酚替诺福韦(TAF)这两种HIV核苷类似物逆转录酶抑制剂(NRTIs)组成的三药组合，单独用作治疗成人和体重至少40 kg的儿童HIV-1感染的治疗方案。",
"治疗领域":[""],
"靶点":[""],
"联系人姓名":"郑丰渠",
"方案是否为联合用药":"否",
"申请人名称":"上海迪赛诺医药集团股份有限公司",
"试验专业题目":"一项随机、开放、四周期、两序列、单剂量、完全重复交叉设计，评价餐后状态下口服多替拉韦恩曲他滨丙酚替诺福韦片（50mg/200mg/25mg）在正常健康成年受试者中的生物等效性研究",
"试验通俗题目":"多替拉韦恩曲他滨丙酚替诺福韦片餐后生物等效性试验",
"首次公示信息日期":"2025-07-10",
"试验状态":"已完成",
"招募状态":"",
"临床申请受理号":[""],
"试验方案编号":"ARL-24-024",
"方案最新版本":"03",
"版本日期":"2024-07-24",
"申办单位信息":[{"联系人姓名":"郑丰渠","申请人名称":"上海迪赛诺医药集团股份有限公司","联系人座机":"021-51323300","联系人手机号":"","联系人Email":"zhengfengqu@desano.com","联系人邮政地址":"上海市-上海市-浦东新区张衡路1479号","联系人邮编": "201203"}]
"试验目的": "主要目的：在正常、健康、成年受试者餐后状态条件下，评价受试制剂（T）：多替拉韦恩曲他滨丙酚替诺福韦片（50mg/200mg/25mg）与参比制剂（R）：Tivicay®（50mg多替拉韦片剂）+ DESCOVY®（200mg恩曲他滨+25mg丙酚替诺福韦片剂）之间的生物等效性。次要目的：考察单次口服剂量下试验药物（IMPs）的安全性和耐受性。",
"试验分类": "生物等效性试验/生物利用度试验",
"试验分期": "BE试验",
"试验设计": "交叉设计",
"随机化": "随机化",
"盲法": "开放",
"试验范围": "其他印度单中心试验",
"受试者信息": [{"key": "年龄", "value": ["18岁(最小年龄)至45岁(最大年龄)"]}, {"key": "性别", "value": ["男+女"]}, {"key": "健康受试者", "value": ["有"]}, {"key": "入选标准", "value": ["1.年龄在18至45岁（含）之间的男性和非妊娠女性受试者。", "2.体重指数（BMI）在18.5至30Kg / m2之间（含临界值），且体重≥50千克。", "3.经基线病史、体格检查和生命体征检查（血压、脉搏率、呼吸率和体温）确定为正常结果的受试者。", "4.血常规、生化、尿常规检查结果正常的受试者。", "5.经12导联心电图和胸部X光检查（如根据任何重大既往病史和/或呼吸系统检查中的阳性发现而需要）结果在临床上可接受的受试者。", "6.愿意遵守方案要求，特别是在给药前48小时至每个研究周期最后一次采血后，避免摄入含黄嘌呤的食物或饮料（巧克力、茶、咖啡或可乐饮料）或葡萄柚汁、任何酒精制品、吸烟和使用烟草产品，并遵守食物、液体和体位的限制。", "7.无严重酗酒史。", "8.最近一个月内无药物滥用史（苯二氮？和巴比妥类药物），最近六个月内无其他非法药物（大麻、可卡因、吗啡、安非他明）滥用史。", "9.受试者同意在整个研究期间使用避孕措施。", "10.包括非吸烟者、前吸烟者和中度吸烟者。“中度吸烟者定义为每天吸烟10支或更少的人，前吸烟者是完全戒烟至少3个月的人。", "11.愿意签署并注明日期的《受试者知情同意书》（SIS）和《知情同意书》（ICF）。"]}, {"key": "排除标准", "value": ["1.已知对多替拉韦、恩曲他滨和丙酚替诺福韦或相关药物有超敏反应史。", "2.在给药日前28天内，要求对具有酶修饰活性的任何疾病进行药物治疗。", "3.在给予试验药物（IMP）前14天内，服用过处方药或非处方药（包括维生素和矿物质）的受试者。", "4.任何可能严重干扰胃肠道、造血器官等功能的医疗或手术状况。", "5.有心血管、肾脏、肝脏、眼科、肺部、神经、代谢、血液、胃肠道、内分泌、免疫或精神疾病史。", "6.在本研究I期给药前90天内参加过临床药物研究或生物等效性研究。", "7.有恶性肿瘤或其他严重疾病史。", "8.在本研究I期给药前90天内献过血。", "9.HIV检测、乙肝表面抗原（HBsAg）或丙型肝炎检测呈阳性的受试者。", "10.呼气酒精测试呈阳性。", "11.尿检药物滥用呈阳性。", "12.有吞咽困难史。", "13.存在任何采血禁忌症。", "14.男性受试者未从筛选日期起至研究结束确认采取避孕措施。禁欲、屏障方法（如避孕套等）是可接受的。", "15.女性受试者血清人绒毛膜促性腺激素（β-hCG）检测呈阳性。", "16.哺乳期妇女（目前正在哺乳）。", "17.使用口服或植入式激素避孕药。", "18.女性受试者未从筛选日期起至研究结束确认采取避孕措施。禁欲、屏障方法（如避孕套、避孕隔膜等）是可接受的。" ]}]
"试验药":[{"data": {"body": [{"h_1026_1": ["中文通用名:多替拉韦恩曲他滨丙酚替诺福韦片", "英文通用名:Dolutegravir, emtricitabine and tenofovir alafenamide tablets", "商品名称:NA"], "h_1026_2": ["剂型:片剂", "规格:多替拉韦50mg、恩曲他滨200mg、丙酚替诺福韦25mg", "用法用量:每周期1片", "用药时程:4周期"]}], "head": {"h_1026_1": "名称", "h_1026_2": "用法"}}, "name": "试验药"}],
"对照药": [{"data": {"body": [{"h_1026_1": ["中文通用名:多替拉韦片", "英文通用名:Dolutegravir Sodium Tablets", "商品名称:TIVICAY"], "h_1026_2": ["剂型:片剂", "规格:50mg", "用法用量:每周期1片", "用药时程:4周期"]}, {"h_1026_1": ["中文通用名:恩曲他滨丙酚替诺福韦片", "英文通用名:Emtricitabine and Tenofovir Alafenamide Fumarate Tablets", "商品名称:DESCOVY"], "h_1026_2": ["剂型:片剂", "规格:恩曲他滨200mg、丙酚替诺福韦25mg", "用法用量:每周期1片", "用药时程:4周期"]}], "head": {"h_1026_1": "名称", "h_1026_2": "用法"}}, "name": "对照药"}],
"主要终点指标及评价时间": [{"指标":"Cmax、AUC0-t和AUC0-inf","评价时间":"整个采血期间","终点指标选择":"有效性指标"}] ,
"次要终点指标及评价时间": [{"指标":"对受试者进行不良事件和严重不良事件的监测。安全性评估将基于体格检查、生命体征测量和临床实验室检查结果进行。","评价时间":"整个试验期间","终点指标选择":"有效性指标"}] ,
"数据安全监查委员会（DMC）": "",
"为受试者购买试验伤害保险": "",
"试验状态信息":[{"data": [{"key": "试验状态", "value": ["已完成"]}, {"key": "目标入组人数", "value": ["国际: 40 ；"]}, {"key": "已入组人数", "value": ["国际: 39 ；"]}, {"key": "实际入组总人数", "value": ["国际: 39 ；"]}, {"key": "第一例受试者签署知情同意书日期", "value": ["国际：2024-08-12；"]}, {"key": "第一例受试者入组日期", "value": ["国际：2024-09-02；"]}, {"key": "试验完成日期", "value": ["国际：2024-10-18；"]}], "name": "试验状态信息"}],
"主要临床机构信息":[{"data": {"body": [{"h_1026_1": ["Himanshukumar Amin"], "h_1026_2": ["MBBS"], "h_1026_3": ["NA"], "h_1026_4": ["0265-2280161-62- 63"], "h_1026_5": ["himanshu.amin@accutestglobal.com"], "h_1026_6": ["上海市-上海市-张衡路1479号"], "h_1026_7": ["390016"], "h_1026_8": ["Accutest Research Laboratories (I) Pvt. Ltd."]}], "head": {"h_1026_1": "姓名", "h_1026_2": "学位", "h_1026_3": "职称", "h_1026_4": "电话", "h_1026_5": "Email", "h_1026_6": "邮政地址", "h_1026_7": "邮编", "h_1026_8": "单位名称"}}, "name": "主要研究者信息"}],
"参与临床机构信息":[{"data": {"body": [{"h_1026_1": ["Accutest Research Laboratories (I) Pvt. Ltd."], "h_1026_2": ["Himanshukumar Amin"], "h_1026_3": ["印度"], "h_1026_4": ["Vadodara"], "h_1026_5": ["1st & 2nd Floor, Synergy Square Complex,Krishna Industrial Estate, B.I.D.C., Gorwa,Vadodara – 390016, India."]}], "head": {"h_1026_1": "机构名称", "h_1026_2": "主要研究者", "h_1026_3": "国家", "h_1026_4": "省（州）", "h_1026_5": "城市"}}, "name": "各参加机构信息"}],
"伦理委员会信息": [{"data": {"body": [{"h_1026_1": ["RANESHWAR MULTISPECIALilY HOSPITAL"], "h_1026_2": ["同意"], "h_1026_3": ["2024-08-02"]}], "head": {"h_1026_1": "名称", "h_1026_2": "审查结论", "h_1026_3": "批准日期/备案日期"}}, "name": "伦理委员会信息"}],
"临床试验结果摘要":[{"data": {"body": [{"h_1026_1": ["D00"], "h_1026_2": ["2024-11-25"]}], "head": {"h_1026_1": "版本号", "h_1026_2": "版本日期"}}, "name": "临床试验结果摘要"}],
"剂型（二级）": "片剂",
"ATC分类": [""],
"试验分类":"生物等效性试验/生物利用度试验",
"申办单位所在地": ["上海市"],
"最新状态日期": "2025-07-10",
}
EXCEL格式
2. 美国临床试验
2.1 概述
本库完整收录美国注册（Clinic.Trial）的全部临床试验信息，涵盖试验设计、招募详情、研究者信息、试验药物、适应症、研发阶段、试验状态及结果等核心内容，实时动态更新，当前数据总量54万+条。
2.2 数据结构与样例
JSON格式
{
"试验登记号": "NCT02332850",
"登记日期": "2015-01-07",
"其他试验登记号": ["NCI-2015-00712", "139511"],
"试验标题":"Phase Ib Study of SAR650984 in Combination With Carfilzomib for Treatment of Relapsed or Refractory Multiple Myeloma",
"正式名称": "A Multi-ARM Phase Ib Study of SAR650984 (Isatuximab, an Anti-CD38 mAb) in Combination With Standard Carfilzomib, and High-dose Weekly Carfilzomib and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma",
"开展国家/地区": ["United States(美国)","Canada(加拿大)"],
"申办单位": ["University of California San Francisco（美国加州大学旧金山分校）"],
"合作方":["Amgen Inc（安进）","Sanofi Inc（赛诺菲）"],
"试验关联记录":[""],
"开始日期": "2015-01-21",
"主要终点完成日期": "",
"结束日期": "",
"结果发布日期": "",
"最近更新日期": "2025-05-01",
"招募状态":"Active, not recruiting（试验进行中，但目前不招募）",
"注册地": "美国",
"药品名称":["Variable regimens including carfilzomib","dexamethasone", "isatuximab(艾沙妥昔单抗)" , "isatuximab + carfilzomib + dexamethasone"],
"药物类别":["肠胃病用药","抗肿瘤药","激素","止吐药","抗炎药","外周神经系统药"],
"干预信息":[{"名称":"isatuximab","干预类型":"生物药"},{"名称":"carfilzomib","干预类型":"药品"},{"名称":"dexamethasone","干预类型":"药品"}],
"靶点":[
{
"全称": "CD38 Molecule（CD38）",
"简称": "CD38",
"中文": "环腺苷二磷酸核糖1",
"别名": [
"CD38",
"CD38 Molecule",
"ADP-Ribosyl Cyclase 1",
"ADP-Ribosyl Cyclase/Cyclic ADP-Ribose Hydrolase 1",
"2'-Phospho-Cyclic-ADP-Ribose Transferase",
"2'-Phospho-ADP-Ribosyl Cyclase",
"Cyclic ADP-Ribose Hydrolase 1",
"NAD(+) Nucleosidase",
"CD38 Antigen (P45)",
"ADPRC 1",
"CADPR1",
"2'-Phospho-ADP-Ribosyl Cyclase/2'-Phospho-Cyclic-ADP-Ribose Transferase",
"Ecto-Nicotinamide Adenine Dinucleotide Glycohydrolase",
"Cluster Of Differentiation 38",
"CADPr Hydrolase 1",
"CD38 Antigen",
"ADPRC1",
"T10"
],
"详情": "https://www.uniprot.org/uniprotkb/P28907"
},
{
"全称": "Proteasome",
"简称": "Proteasome",
"中文": "蛋白酶体",
"别名": [
"26S proteasome",
"26S proteasome complex",
"Proteasome",
"Proteasome Complex"
],
"详情": ""
},
{
"全称": "Ubiquitin",
"简称": "Ubiquitin",
"中文": "泛素化",
"别名": [
"40S ribosomal protein S27a",
"60S ribosomal protein L40",
"CEP80",
"epididymis luminal protein 112",
"HEL112",
"HUBCEP80",
"Ribosomal protein L40",
"ribosomal protein S27a",
"Ribosomal protein S27a, transcript variant 1",
"RPS27A",
"RPS27A variant 1",
"RS27A_HUMAN",
"S27A",
"Small ribosomal subunit protein eS31",
"UBA80",
"UBC",
"UBCEP1",
"UBCEP80",
"Ubiquitin",
"ubiquitin and ribosomal protein S27a",
"ubiquitin C",
"Ubiquitin carboxyl extension protein 52",
"Ubiquitin carboxyl extension protein 80",
"Ubiquitin-40S ribosomal protein S27a",
"Ubiquitin-52 amino acid fusion protein",
"Ubiquitin-CEP52",
"ubiquitin-CEP80"
],
"详情": "https://www.uniprot.org/uniprotkb/P62979"
}
],
"作用机制":[
{
"en": "ADP ribosyl cyclase-1 inhibitor",
"cn": "环腺苷二磷酸核糖1抑制剂"
},
{
"en": "Proteasome inhibitor",
"cn": "蛋白酶体抑制剂"
},
{
"en": "Ubiquitin inhibitor",
"cn": "泛素化抑制剂"
}
],
"工艺技术":[
{
"en": "Biological",
"cn": "生物药"
},
{
"en": "Formulation powder",
"cn": "粉末制剂"
},
{
"en": "Freeze drying",
"cn": "冻干制剂"
},
{
"en": "Immunoglobulin G isotype antibody",
"cn": "免疫球蛋白G同型抗体"
},
{
"en": "Infusion",
"cn": "输注"
},
{
"en": "Intravenous formulation",
"cn": "静脉注射剂"
},
{
"en": "Monoclonal antibody humanized",
"cn": "人源化单克隆抗体"
},
{
"en": "Oral formulation",
"cn": "口服制剂"
},
{
"en": "Peptide",
"cn": "肽"
},
{
"en": "Solution",
"cn": "溶液剂"
},
{
"en": "Subcutaneous formulation",
"cn": "皮下注射剂"
}
],
"适应症":[
{
"en": "multiple myeloma",
"cn": "多发性骨髓瘤"
}
],
"参考适应症": [
{
"en": "multiple myeloma",
"cn": "多发性骨髓瘤"
}
],
"治疗领域": [
"癌症及其他肿瘤",
"血液和淋巴系统疾病",
"心血管系统疾病",
"免疫性疾病"
],
"试验阶段": {
"en": "Phase 1 Clinical",
"cn": "Ⅰ期"
},
"试验类型": [
{
"en": "Interventional",
"cn": "干预性研究"
}
],
"实验目标": [
{
"en": "Treatment",
"cn": "治疗性"
}
],
"干预类型": [
{
"en": "Biological",
"cn": "生物药"
},
{
"en": "Drug",
"cn": "药品"
}
],
"干预分组方式": "随机化",
"干预模型": "平行设计",
"盲法": "开放标签",
"设盲对象": "",
"观察模型": "",
"观察时间点": "",
"患者登记研究": "",
"患者登记随访持续时间": "",
"生物标本存放形式": "",
"生物标本说明": "",
"生物标记物类型": "Biochemical; Genomic; Proteomic",
"生物标标记物作用": "Therapeutic effect marker; Toxic effect marker",
"终点类型": [
{
"en": "Safety",
"cn": "安全性"
},
{
"en": "Efficacy",
"cn": "有效性"
},
{
"en": "Pharmacokinetics",
"cn": "药代动力学"
},
{
"en": "Pharmacodynamics",
"cn": "药效学"
}
],
"主要终点指标": [
{
"指标": "ARM I: Incidence of Dose-Limiting Toxicities (DLT)",
"评价时间": "Up to 60 days of the last dose of study drug",
"描述": "Treatment-related Adverse events resulting in a DLT will be summarized by maximum toxicity grade for each dose level of isatuximab."
},
{
"指标": "ARM I: Maximum tolerated dose (MTD) of isatuximab",
"评价时间": "At the end of Cycle 1 (each cycle is 28 days)",
"描述": "The MTD is defined as the dose level below the lowest dose that induces dose- limiting toxicity in at least one-third of patients Adverse events will be summarized by maximum toxicity grade and by dose level for each ARM of the trial using NCI CTCAE v4.03"
},
{
"指标": "ARM II: Overall Response Rate (ORR)",
"评价时间": "Up to 60 days of the last dose of study drug",
"描述": "Overall response rate (ORR) as define by the International Myeloma Working Group (IMWG) uniform response criteria of patients obtaining Stringent Complete Remission (sCR), Complete Remission (CR), Very Good Partial Remission (VGPR), Partial Remission (PR), or Minimal Remission (MR)"
}
],
"次要终点指标": [
{
"指标": "ARM I: Pharmacokinetic (PK) profile of isatuximab",
"评价时间": "Baseline, 2 hours mid-infusion, 4, 7, and 11 hours after end of infusion on day 1, days 2, 3, 8, and 15 of course 1, and 0 and 4 hours after end of infusion on day 1 of courses 2-8 (and 0 hours on day 15 of course 2 only)",
"描述": "Individual plasma concentrations and PK parameters of SAR650984 will be tabulated with standard descriptive statistics. Pharmacokinetic analyses will be carried out in the Pharmacokinetics, Dynamics and Metabolism Department at Sanofi for SAR650984 and carfilzomib."
},
{
"指标": "ARM I: Overall Response Rate (ORR)",
"评价时间": "Up to 60 days of the last dose of study drug",
"描述": "Overall response rate; defined as sCR+CR+VGPR + PR utilizing IMWG Uniform Response Criteria"
},
{
"指标": "ARM I: Clinical benefit response (CBR)",
"评价时间": "Up to 60 days of the last dose of study drug",
"描述": "defined as CR + VGPR + PR + minor response (MR), utilizing International Myeloma Working Group (IMWG) Uniform Response Criteria"
},
{
"指标": "ARM I: Incidence of isatuximab-specific antidrug antibodies (ADA)",
"评价时间": "Up to 1 year",
"描述": "Analysis of Incidence of isatuximab-specific antidrug antibodies (ADA) to be performed by Sanofi-Oncology."
},
{
"指标": "ARM I: Percentage of bone marrow cells expressing cell surface determinant, CD38 and receptor density",
"评价时间": "Up to 30 days of the last dose of study drug",
"描述": "The overall percentage of bone marrow cells expressing cell surface determinant, CD38 and receptor density will be reported."
},
{
"指标": "Overall survival (OS)",
"评价时间": "assessed at 1, 2, and 3 years from start of treatment",
"描述": "Duration of time from start of treatment to death on study from any cause,"
},
{
"指标": "Progression Free Survival (PFS)",
"评价时间": "from start of treatment up to 1 year",
"描述": "Duration of time from start of treatment to the first occurrence of disease progression or death on study from any cause, whichever occurs earlier,"
},
{
"指标": "Time To Progression (TTP)",
"评价时间": "from start of treatment up to 1 year",
"描述": "Defined as the duration from start of treatment until the first occurrence of disease progression with deaths from causes other than disease progression, censored"
},
{
"指标": "Duration of Response (DOR)",
"评价时间": "up to 60 days of the last dose of study drug",
"描述": "The duration of overall response is defined as the time period when criteria are met for MR or better (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. The duration of CR is defined as the time when criteria are first met for CR until the first date that IMWG relapse is objectively documented"
},
{
"指标": "Changes in pharmacodynamics variables as they relate to dose, response, and toxicity of carfilzomib in combination with isatuximab",
"评价时间": "Baseline to up to 30 days of the last dose of study drug",
"描述": "Changes from baseline in pharmacodynamic markers and proliferation markers, will be evaluated and summarized for each dose cohort."
}
],
"其他终点指标": [ ],
"临床试验相关文献": [ ],
"首例受试者入组日期": "2015-01-07",
"目标入组人数": "",
"实际入组人数": "83",
"年龄范围": "18 Years - No limit",
"性别": "Male and Female",
"是否接受健康受试者": "No",
"入组期限": "110.39 Months",
"入组率": "0.75 Patients/Month",
"联系人信息": [{"联系人类别":"","姓名":"","联系方式":""}],
"试验点信息": [
"University of California, San Francisco",
"Colorado Blood Cancer Institute",
"Princess Margaret Cancer Centre",
"Sarah Cannon Cancer Center",
"Icahn School of Medicine at Mount Sinai",
"Hackensack University Medical Center"
]，
"临床试验结果": [{"结果名称":"Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients","结果链接":"https://clinicaltrials.gov/study/NCT03275285?rank=3&tab=results"}],（样例数据）
"试验文件": [{"文件名称":"Study Protocol","文件链接":"https://cdn.clinicaltrials.gov/large-docs/85/NCT03275285/Prot_002.pdf"}],（样例数据）
}
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