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: 8132960
• 负责人: William M Lee
• 金额: $ 25.97万
• 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/8132960
• 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; 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; immune activation; 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）： 药物诱导的肝损伤（DILI）是临床医学中遇到的最困难的问题之一。意外的DILI阻碍了多种有效药物的药物开发。许多代理商已获得批准或几乎被批准，但由于严重甚至致命的DILI，未能获得广泛接受。批准前试验的尺寸很小，这意味着不会捕获不频繁的事件。因此，由于毒品而导致的不良事件及其特征对所有美国人的健康至关重要，积极进取，健壮且测量的方法是为不良事件而进行的销售后监视方法。药物引起的肝损伤网络（DILIN）在最初的五年内奠定了基础工作，已经建立了可以将来更广泛使用的系统。因此，存在一个机会，可以增强捕获其他销售后diLi案件，以提高我们对其原因的理解。可能是它的治疗。由于以下原因，UT Southwestern非常适合成为稀释场所：1）达拉斯堡沃思堡Metroplex构成了超过650万人的广泛多样化的城市/郊区人口。 2）研究人员在DILI和临床试验开发方面具有特定而良好的经验，我们的具体建议包括：1）该地区的临床医生顾问委员会参考病例。我们将经常咨询他们，为他们的电话提供1-800个号码，并访问网站以在服务更新和讨论引起DILI的重要性。 2）我们将利用研究人员在急性肝衰竭研究中的经验来扩展和鼓励利用DILI生物材料的进一步辅助研究。当前正在我们机构正在研究的大量西班牙裔人口中，应有特定的物质。 3）我们提出了一项使用N-乙酰半胱氨酸的治疗试验，以符合符合近似于Hy Zimmerman定律的严重伤害标准的DILI病例，即与伴随的Jaundice的急性疾病。