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: 10731578
• 负责人: ANDREW Abba STOLZ
• 金额: $ 36.28万
• 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 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10731578
• 关键词: Acute; Ancillary Study; Assessment tool; Cell Death; Cholestasis; Clinical Treatment; Collection; County; Data Coordinating Center; Databases; Development; Endoplasmic Reticulum; Enrollment; Etiology; Event; Future; Herbal supplement; Immune; Immune checkpoint inhibitor; Knowledge; Los Angeles; Mediating; Medicine; Mitochondria; Natural Immunity; Patients; Pharmaceutical Preparations; Pilot Projects; Plant Preparations; Population Heterogeneity; Proteins; Protocols documentation; Research Personnel; Resources; Role; Scientific Advances and Accomplishments; Talents; Underrepresented Populations; United States; United States National Institutes of Health; Vitamins; Work; acute liver injury; clinical center; dietary supplements; drug induced liver injury; ethnic diversity; follow-up; hepatocellular injury; inhibitor; liver injury; medical schools; novel; patient population; pharmacovigilance; phase 2 study; preservation; research clinical testing; response; shared database; treatment trial

The USC-UCLA Drug-Induced Liver Injury Clinical Center (CC) proposal in response to RFA-DK-22-013 “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 9.8 M residents of Los Angeles County (2022) 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 herbal and dietary supplements (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 DILI case from under represented populations and HDS agents with proposed biospecimens collections for future studies.; 2) Specific Aim 2: Mechanism of cell death and the role of innate immunity in Immune-Mediated Liver Injury due to Checkpoint Inhibitors (ILICI) (Ancillary Study); 3) Specific Aim 3: Proposed Clinical Treatment Trial for Cholestatic and Acute Liver Injury and 4) Specific Aim 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. .

USC-UCLA 药物性肝损伤临床中心 (CC) 针对 RFA-DK-22-013 的提案 “延续药物性肝损伤网络（DILIN）临床中心”希望继续参与 我们将继续与其他 CC 合作，推进 DILI 的科学知识和临床评估。 将洛杉矶县仅有的两所医学院合并起来，使我们能够独特地捕捉和 将 DILI 案例登记到由数据协调中心 (DCC) 监管的网络数据库中。 980 万。 洛杉矶县 (2022) 的居民是无与伦比的资源，由最多元化的种族组成 我们的建议继续利用凯克学院的专业知识和人才。 南加州大学医学院和加州大学洛杉矶分校大卫格芬医学院大量善意招生。 和患病患者的密切随访证明了我们的 CC 有能力在这种多样化的情况下捕获 DILIN 病例 在我们的国家中，除了草药和膳食补充剂 (HDS) 之外，DILI 病因几乎没有重叠的人群 继续开展 USC-UCLA DILI CC 的具体目标是： 1) 继续从代表性不足的人群和 HDS 代理人中招募高质量的真实 DILI 病例 以及拟议的生物样本收集以供未来研究。；2) 具体目标 2：细胞死亡机制和 先天免疫在检查点抑制剂引起的免疫介导的肝损伤中的作用 (ILICI)（辅助研究 3）； 具体目标 3：针对胆汁淤积和急性肝损伤的拟议临床治疗试验和 4) 具体目标 4： 继续支持 DILIN 开发因果关系评估工具和开发试点的努力 针对药物或 HDS 引起的不良肝损伤的药物警戒方案项目。 。

项目成果

Liver injury from herbal and dietary supplements.

草药和膳食补充剂造成的肝损伤。

• 发表时间: 2017-01
• 作者: Navarro, Victor J;Khan, Ikhlas;Björnsson, Einar;Seeff, Leonard B;Serrano, Jose;Hoofnagle, Jay H
• 通讯作者: Hoofnagle, Jay H

Ashwagandha-induced liver injury: A case series from Iceland and the US Drug-Induced Liver Injury Network.

Ashwagandha 引起的肝损伤：来自冰岛和美国药物引起的肝损伤网络的病例系列。

• 发表时间: 2020
• 作者: Björnsson, Helgi K;Björnsson, Einar S;Avula, Bharathi;Khan, Ikhlas A;Jonasson, Jon G;Ghabril, Marwan;Hayashi, Paul H;Navarro, Victor
• 通讯作者: Navarro, Victor

Leflunomide-induced liver injury: Differences in characteristics and outcomes in Indian and US registries.

来氟米特诱发的肝损伤：印度和美国登记处的特征和结果差异。

• 发表时间: 2022-06
• 作者: Devarbhavi, Harshad;Ghabril, Marwan;Barnhart, Huiman;Patil, Mallikarjun;Raj, Sujata;Gu, Jiezhun;Chalasani, Naga;Bonkovsky, Herbert L
• 通讯作者: Bonkovsky, Herbert L

Incidence of Hepatitis E Infection in American Patients With Suspected Drug-Induced Liver Injury Is Low and Declining: The DILIN Prospective Study.

疑似药物性肝损伤的美国患者中戊型肝炎感染的发病率较低且呈下降趋势：DILIN 前瞻性研究。

• 发表时间: 2022-09-01
• 作者: Fontana, Robert John;Engle, Ronald E;Hayashi, Paul H;Gu, Jiezhun;Kleiner, David E;Nguyen, Hahn;Barnhart, Huiman;Hoofnagle, Jay H;Farci, Patrizia
• 通讯作者: Farci, Patrizia

ERAP-1 and ERAP-2 Variants in Liver Injury After COVID-19 mRNA Vaccination: A US Multicenter Study.

COVID-19 mRNA 疫苗接种后肝脏损伤中的 ERAP-1 和 ERAP-2 变异：一项美国多中心研究。

• 发表时间: 2024-03-25
• 作者: Fontana, Robert J;Li, Yi Ju;Vuppalanchi, Raj;Kleiner, David E;Gu, Jiezhun;Shroff, Hersh;Van Wagner, Lisa B;Watkins, Paul B;US DILIN study group
• 通讯作者: US DILIN study group