英国临床试验

概述

收录英国注册临床试验信息，涵盖基本信息、药物及适应症信息、试验详情、招募信息、研究者信息、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2万6千余条。

数据结构及样例

{
  "试验登记号":"  ISRCTN73887615",
  "英国官网链接":"https://www.isrctn.com/ISRCTN73887615",
  "登记日期":"2018-10-10", 
  "其他试验登记号":["RG_17-229","IRAS248487"],
  "试验标题":"Carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis",
  "正式的科学名称":"CArvediloL versus varIceal Band ligation in primary pREvention of variceal bleeding in liver cirrhosis",
  "试验简称":"CALIBRE",
  "国家/地区":"England（英格兰）Northern Ireland, Scotland, United Kingdom（英国）,Wales",
  "开始日期":"2018-03-01",
  "结束日期":"2024-05-31",
  "最近更新日期":"2025-04-28",
  "招募状态":"No longer recruiting（不再招募）",
  "注册机构":"英国",
  "药品名称":"Carvedilol",
  "干预信息":"序号 : 名称 : 干预类型 1 : Carvedilol : Drug",
  "适应症":"variceal bleeding in liver cirrhosis",
  "治疗领域":"消化系统疾病",
  "试验阶段":"Phase 3 Clinical（Ⅲ期）",
  "试验类型":"Interventional（干预性研究）",
  "试验目标":"Treatment（治疗性）",
  "干预类型":"Drug（药品）",
  "终点类型":"",
  "试验设计":"Interventional prospective multicentre pragmatic open-label two-arm randomized controlled parallel group trial with internal pilot",
  "试验方案":"After participant eligibility has been confirmed and informed consent has been received, the participant can be randomised into the trial. A Randomisation Form will be ……stored in a confidential document at BCTU.Participants will be in the study for a total duration of 12 months from the point of randomisation.", 
  "主要的疗效判定指标":"Any variceal bleeding within 12 months of randomisation, assessed through endoscopy for the variceal band ligation (VBL) and through observation for the carvedilol arm at 4 weeks and after 6 and 12 months",
  "次要的疗效判定指标":"1. Time to first variceal bleed in days from randomisation, assessed through endoscopy for the variceal band ligation (VBL) and through observation for the carvedilol arm at 4 weeks and after 6 and 12 months. 2. Mortality at 12 months from randomisation,assessed using medical records and staff notification after 6 and 12 months:2.1. All-cause mortality.2.2. Liver-related mortality",  
  "目标入组人数":"2630",
  "实际入组人数":"266",
  "受试者人群":"Patient",
  "年龄范围":"20 years - No limit",
  "性别":"Both",
  "入选标准":"1. Liver cirrhosis as defined clinically, radiologically (USS and transient elastography), or on histology.2. Medium varices (Grade II varices that do not flatten on air insufflation and do not occlude the lumen) and large varices (Grade III varices which are larger than Grade II varices and occupy the whole lumen) that have never bled as defined in the BSG guidelines.3. Aged 18 years or older",
  "排除标准":"Current exclusion criteria as of 24/11/2021:1. Age <18 years.2. Pregnant or lactating women.3. Known intolerance or contraindications to beta-blockers including asthma",
  "申办单位":"University of Birmingham",
  "合作单位":"Health Technology Assessment Programme",
  "联系人信息":"序号 : 联系人类别 : 姓名 : 联系方式1 : 试验联系人 : Dr Lisa Holden : +44 (0)121 414 7943;l.m.holden@bham.ac.uk",
  "是否有临床试验结果":"是",
  "临床试验结果":"序号 : 文献内容 : 文献链接 1 : Protocol article : https://doi.org/10.1136/bmjgast-2019-000290/ 2 : Results article :https://pubmed.ncbi.nlm.nih.gov/40241373/",
  "试验停止原因":"",
  "试验文件":"序号 : 文献内容 : 文献链接1 : HRA research summary : https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/calibre-2/. 2 : Protocol file : https://www.isrctn.com/editorial/retrieveFile/750160ec-59b8-4c9a-90bc-c042ae324417/35827",
}