概述
收录注册于美国的所有临床试验信息,涵盖临床试验基本信息、临床试验设计、患者招募信息、研究者信息、药物信息、适应症、临床研发阶段、临床试验状态以及临床试验结果等内容,目前收录信息约五十三万余条。
数据结构及样例
{
"试验登记号": "NCT00000450",
"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",
"正式的科学名称": "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",
"国家/地区": ["United States(美国)","Canada(加拿大)"],
"开始日期": "2015-01-21",
"首例受试者入组日期": "2015-01-07",
"主要终点完成日期": "2021-10-14",
"结束日期": "",
"结果发布日期": "2025-01-01",
"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)"],
"注册机构": "美国",
"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)"],
"药品名称":["Variable regimens including carfilzomib","dexamethasone", "isatuximab(艾沙妥昔单抗)" , "isatuximab + carfilzomib + dexamethasone"],
"干预信息": [{"名称":"isatuximab","干预类型":"生物药"},{"名称":"dexamethasone","干预类型":"药品"},{"名称":"carfilzomib","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 Antigen","ADPRC1","T10"],"详情":"https://www.uniprot.org/uniprotkb/P28907"}],
"作用机制": ["ADP ribosyl cyclase-1 inhibitor(环腺苷二磷酸核糖1抑制剂)","Proteasome inhibitor(蛋白酶体抑制剂)","Ubiquitin inhibitor(泛素化抑制剂)"],
"适应症": ["multiple myeloma(多发性骨髓瘤)"],
"工艺技术": ["Biological(生物药)","Formulation powder(粉末制剂)","Freeze drying(冻干制剂)","Solution(溶液剂)","Subcutaneous formulation(皮下注射剂)"],
"治疗领域": ["癌症及其他肿瘤","心血管系统疾病","血液和淋巴系统疾病","免疫性疾病"],
"试验阶段": ["Phase 1 Clinical(Ⅰ期)"],
"试验类型": ["Interventional(干预性研究)"],
"试验目标":["Treatment(治疗性)"],
"干预类型": ["Biological(生物药)","Drug(药品)"],
"干预分组方式": "随机化",
"干预模型": "平行设计",
"盲法": "单盲",
"设盲对象": "结果评价人员",
"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": "",
"生物标记物作用": "Male and Female",
"性别": "Male and Female",
"性别": "Male and Female",
"终点类型":["Safety(安全性)","Efficacy(有效性)","Pharmacokinetics(药代动力学)","Pharmacodynamics(药效学)"] ,
"主要终点指标": [{"指标":"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."}],
"次要终点指标": [{"指标":"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."}],
"其他终点指标": [{"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,"}],
"目标入组人数": "80",
"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":"试验联系人","姓名":"Clinical Trials Referral Office","联系方式":"mayrstudies@mmmn.edu"}],
"试验点信息": ["Princess Margaret Cancer Centre","Icahn School of Medicine at Mount Sinai","Colorado Blood Cancer Institute","University of California, San Francisco","Sarah Cannon Cancer Center","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"}],
"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"}],
}