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.

项目总结/摘要 USC-UCLA药物性肝损伤临床中心（CC）提案对RFA-DK-17-509的回应 “药物性肝损伤网络（DILIN）临床中心延续的有限竞争” 希望继续与其他CC一起参与，以推进科学知识和临床评价 关于DILI我们的建议将继续联合收割机只有两个医学院在洛杉矶县允许我们 能够唯一捕获DILI病例并将其登记到由数据监督的网络数据库中 协调中心（DCC）。洛杉矶县（2016年）的1010万居民是无与伦比的资源 由美国最多种族的人口组成。我们的建议继续利用 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。 大量真实和患病患者的入组以及密切随访证明了我们的CC 能够在这一不同人群中捕获DILIN病例，除了DILI之外，DILI的病因几乎没有重叠 我们各自患者人群中的HDS。USC-UCLA DILI CC延续的具体目标 目的是：1）继续从代表性不足和儿科患者中招募高质量的真实DILIN病例 重点是增加急性病例的入组; 2）开发治疗试验， 胆汁淤积性肝损伤; 3）急性肝细胞损伤治疗试验的开发;和4）续 支持DILIN开发因果关系评估工具的努力，并制定一个试点项目， 药物或HDS引起的不良肝损伤的药物警戒方案。