UT Southwestern: Clinical Site for the Drug-Induced Liver Injury Network

德州大学西南医学中心：药物性肝损伤网络临床​​站点

• 批准号: 7693775
• 负责人: William M Lee
• 金额: $ 25.87万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 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 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7693775
• 关键词: Acetylcysteine; Acute; Acute Liver Failure; Adverse event; American; Ancillary Study; Area; Biocompatible Materials; Clinical Medicine; Clinical Trials; Consult; Development; Enrollment; Environment; Event; Future; Gastroenterology; Health; Hispanics; Hospitals; Icterus; Immunologic Markers; Injury; Institutes; Institution; Laws; Liver; Marketing; Measures; Newsletter; Patient Care; Pharmaceutical Preparations; Physicians; Randomized Controlled Trials; Reporting; Research Personnel; Role; Services; Severities; Site; Site Visit; Suburban Population; System; Therapy Clinical Trials; Update; Visit; clinical practice; clinical research site; cytokine; drug development; experience; improved; interest; meetings; named group; non-alcoholic fatty liver; post-market

DESCRIPTION (provided by applicant): Drug-induced liver injury (DILI) is one of the most difficult problems encountered in clinical medicine. Unexpected DILI has hampered drug development for a multitude of effective drugs. Many agents have been approved or nearly approved but failed to gain widespread acceptance because of severe and sometimes fatal DILI. The small size of pre-approval trials means that infrequent events will not be captured. Thus, aggressive, robust, and measured approaches to post-marketing surveillance for adverse events due to drugs and their characterization is vital to the health of all Americans. The Drug-Induced Liver Injury Network (DILIN) has made a strong start in laying the groundwork in its first 5 years, having put in place systems that can be used more widely in the future. Thus, an opportunity exists to enhance capture of additional cases of post-marketing DILI so as to improve our understanding of its causes and. potentially, its treatment. UT Southwestern is ideally suited to become a DILIN site for the following reasons: 1) the Dallas Fort Worth metroplex constitutes a widely diverse urban/suburban population of over 6.5 million people. 2) the investigators have specific and strong experience in DILI and clinical trials development, Our specific proposals include: 1) An advisory board of clinicians in the region to refer cases. We will consult them frequently, provide a 1-800 number for their calls and visit sites for in service updates and discussion of drugs of importance in causing DILI. 2) We will utilize the experience of the investigators in the Acute Liver Failure Study to expand and encourage further ancillary studies utilizing DILI biomaterials. Specific substudies should be possible with the large Hispanic population currently under study at our institution. 3) We propose a therapeutic trial using N-acetylcysteine for DILI cases that meet criteria for severe injury approximating Hy Zimmerman's law, that is, an acute illness with attendant jaundice.

描述（由申请人提供）： 药物性肝损伤（DILI）是临床医学遇到的最棘手的问题之一。意外的 DILI 阻碍了多种有效药物的开发。许多药物已经获得批准或接近批准，但由于严重甚至有时致命的 DILI 而未能获得广泛接受。预批准试验的规模较小，意味着不会捕获罕见事件。因此，采取积极、稳健和谨慎的方法对药物不良事件及其特征进行上市后监测对于所有美国人的健康至关重要。药物性肝损伤网络 (DILIN) 在前 5 年中奠定了良好的基础，建立了可在未来更广泛使用的系统。因此，我们有机会加强对更多上市后 DILI 病例的捕获，以提高我们对其原因的理解。潜在的，它的治疗。 UT Southwestern 非常适合成为 DILIN 站点，原因如下： 1) 达拉斯沃斯堡大都市拥有广泛多样化的城市/郊区人口，人口超过 650 万。 2）研究者在DILI和临床试验开发方面拥有具体而丰富的经验，我们的具体建议包括：1）在该地区建立一个临床医生顾问委员会来转介病例。我们将经常咨询他们，提供 1-800 电话号码供他们拨打，并访问网站以获取服务更新和讨论导致 DILI 的重要药物。 2) 我们将利用急性肝衰竭研究中研究者的经验来扩大和鼓励利用 DILI 生物材料进行进一步的辅助研究。对于我们机构目前正在研究的大量西班牙裔人口，应该可以进行具体的亚组研究。 3) 我们建议使用 N-乙酰半胱氨酸治疗 DILI 病例，这些病例符合近似 Hy Zimmerman 定律的严重损伤标准，即伴有黄疸的急性疾病。