USC-UCLA Drug-Induced Liver Injury (DILI) Clinical Center.

USC-UCLA 药物性肝损伤 (DILI) 临床中心。

• 批准号: 9769701
• 负责人: ANDREW Abba STOLZ
• 金额: $ 35.3万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-30 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9769701
• 关键词: Acute; Assessment tool; Childhood; Clinical; County; Data Coordinating Center; Databases; Development; Device or Instrument Development; Drug Evaluation; Enrollment; Etiology; Event; Fibroblast Growth Factor; Future; Injury; Knowledge; Los Angeles; Medicine; Patients; Pharmaceutical Preparations; Pilot Projects; Plant Preparations; Population; Population Heterogeneity; Protocols documentation; Research Personnel; Resources; Scientific Advances and Accomplishments; Supervision; Talents; United States; United States National Institutes of Health; Variant; Vitamins; Work; ethnic diversity; follow-up; inhibitor/antagonist; liver injury; medical schools; patient population; pharmacovigilance; phase 2 study; research clinical testing; response; treatment trial

Project Summary/Abstract The USC-UCLA Drug-Induced Liver Injury Clinical Center (CC) proposal in response to RFA-DK-17-509 “Limited Competition for the Continuation of the Drug Induced Liver Injury Network (DILIN) Clinical Centers” hopes to continue to participate with the other CCs to advance the scientific knowledge and clinical evaluation of DILI. Our proposal will continue to combine the only two medical schools in Los Angeles County allowing us to be able to uniquely capture and enroll DILI cases into the Networks database supervised by the Data Coordinating Center (DCC). The 10.1 M residents of Los Angeles County (2016) are an unmatched resource composed of the most ethnically diverse population in the United States. Our proposal continues to utilize the expertise and talents from Keck School of Medicine of USC and David Geffen School of Medicine at UCLA. The enrollment of a large number of bona fide and ill patients with close follow up has demonstrated our CC’s ability to capture DILIN cases in this diverse populations with little overlap in etiology for DILI other than for HDS in our respective patient populations. The Specific Aims for the continuation of the USC-UCLA DILI CC are to: 1) Continued enrollment of high quality bona fide DILIN case from under represented and Pediatric populations with emphasis on increasing enrollment of acute cases; 2) Development of a treatment trial for cholestatic liver injury; 3) Development of a treatment trial for acute hepatocellular Injury; and 4) Continued support of the DILIN’s effort to develop causality assessment instruments and development of a pilot project for a pharmacovigilance protocol for adverse liver injury due to medication or HDS.

项目概要/摘要 USC-UCLA 药物性肝损伤临床中心 (CC) 针对 RFA-DK-17-509 的提案 “继续药物性肝损伤网络 (DILIN) 临床中心的有限竞争” 希望继续与其他CC一起参与，以推进科学知识和临床评估 我们的提案将继续合并洛杉矶县仅有的两所医学院。 能够独特地捕获 DILI 案例并将其登记到由数据监管的网络数据库中 洛杉矶县 1010 万居民（2016 年）是无与伦比的资源。 我们的提案继续利用美国最多元化的人口。 来自南加州大学凯克医学院和加州大学洛杉矶分校大卫格芬医学院的专业知识和人才。 大量真实患病患者的入组以及密切随访证明了我们CC的 能够在这个不同的人群中捕获 DILIN 病例，除了 DILI 之外，其他 DILI 的病因学几乎没有重叠 我们各自患者群体中的 HDS 继续实施 USC-UCLA DILI CC 的具体目标。 目的是： 1) 继续招募来自代表性不足和儿科的高质量真实 DILIN 病例 重点关注增加急性病例的入组人数；2) 开展治疗试验 胆汁淤积性肝损伤；3) 开发急性肝细胞损伤的治疗试验；4) 继续； 支持 DILIN 开发因果关系评估工具和开发试点项目的努力 针对药物或 HDS 引起的不良肝损伤的药物警戒方案。