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欧盟临床试验ctr

收录欧盟CTR注册的临床试验信息，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126000余条。
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概述

收录欧盟CTR注册的临床试验信息，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126000余条。

数据结构及样例

{
  "试验登记号":"2015-003958-41",
  "官网链接":"https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003958-41/NL",
  "登记日期":"",
  "其他试验登记号":["NSR-REP-01","Biogen-protocol-273CH301","NCT03496012"],
  "试验标题":"Trial of a Gene Therapy for the Treatment of Chorioderemia",
  "正式科学名称":"A Single-Masked, Randomised, Controlled, Parallel Group, Phase 3 Clinical Trial Of Retinal Gene Therapy For Choroideremia Using An Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1)",
  "试验简称":"STAR Study",
  "国家主管机构":"丹麦",
  "国家/地区":["Brazil（巴西）","Canada（加拿大）","United States（美国）","United Kingdom（英国）","France（法国）","Denmark（丹麦）","Finland（芬兰）","Germany（德国）","Netherlands（荷兰）"],
  "开始日期":"2016-10-31",
  "结束日期":"2020-12-01",
  "最近更新日期":"2016-04-11",
  "试验状态":"Completed（试验结束）",
  "招募状态":"", 
  "注册机构":"欧盟",
  "干预类型":["Biological（生物药）","Gene therapy（基因疗法）"],
  "药品信息":[{"药品名称":"","活性成分":"timrepigene emparvovec","药物剂型":"Suspension for injection","给药途径":"Intraocular use","药物类型":"","商品名":"","持证商":""}],
  "适应症":["choroideremia（脉络膜缺损）"],
  "治疗领域":["眼疾病"],
  "试验阶段":"Phase 3 Clinical（Ⅲ期）",
  "试验目标":["Treatment（治疗性）"],
  "干预分组方式":"随机化",
  "盲法":"开放标签",
  "对照类型":"其他",
  "设计类型":"平行设计,其他", 
  "组数":"3",
  "终点类型":["Safety（安全性）","Efficacy（有效性）"],
  "主要疗效":[{"判定指标1":"Change from baseline in best corrected visual acuity (BCVA).",
"时间节点1":"BCVA assessments will be performed as per protocol."}],
  "次要疗效":[{"判定指标1":"Visual assessments will be performed as per protocol.","时间节点1":"Safety assessments will be performed at all timepoints."}],
  "目标入组人数":"100",
  "年龄范围":"18-64 years",  
  "受试者性别":"Male",
  "受试者范围":"Patients",
  "入选标准":[
    "Subjects are eligible for study participation if they meet all of the following inclusion criteria.",
    "1. Are willing and able to provide informed consent for participation in the study.",
    "2. Are male and ≥18 years of age.",
    "3. Have a genetically-confirmed diagnosis of CHM.",
    "4. Have active disease clinically visible within the macular region in the study eye.",
    "5. Have reduced visual acuity in the study eye"],
  "排除标准":[
    "Subjects are not eligible for study participation if they meet any of the following exclusion criteria.",
    "- Any significant disease/disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study.",
    "- Have participated in another research study involving an investigational product in the past 12 weeks or received a gene/cell-based therapy at any time previously."],
  "申办单位":["NightstaRx Ltd"],
  "合作单位":[""],
  "联系人信息":[{"联系人类别":"试验联系人","姓名":"NightstaRx Ltd,Clinical Operations Department", "联系方式":"4402076112077"}],
  "是否有临床试验结果":"是",
  "临床试验结果":[{
    "text":"A Randomised, Open Label, Outcomes-Assessor Masked, Prospective, Parallel Controlled Group, Phase 3 Clinical Trial of Retinal Gene Therapy for Choroideremia Using an Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1) [STAR]",
    "url":"https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003958-41/results"}],
  "试验文件":[{"text":"德国,试验结束","url":"https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003958-41/DE"}
{"text":"芬兰,试验结束","url":"https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003958-41/FI"}
{"text":"丹麦,试验结束","url":"https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003958-41/DK"}],
}