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: 7928729
• 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/7928729
• 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）： 药物性肝损伤（DILI）是临床医学面临的难题之一。意外的DILI阻碍了许多有效药物的药物开发。许多药物已被批准或接近批准，但由于严重且有时致命的DILI而未能获得广泛接受。批准前试验的规模较小意味着不会捕获罕见事件。因此，积极的，稳健的，和衡量的方法，上市后监测不良事件，由于药物及其表征是至关重要的健康，所有美国人。药物性肝损伤网络（DILIN）在其前5年的基础工作中取得了良好的开端，建立了可在未来更广泛使用的系统。因此，有机会加强对上市后DILI额外病例的采集，以提高我们对其原因的理解。潜在的治疗。UT西南非常适合成为DILIN网站，原因如下：1）达拉斯沃斯堡大都市构成了一个广泛多样的城市/郊区人口超过650万人。2)研究者在DILI和临床试验开发方面具有具体和丰富的经验，我们的具体建议包括：1）该地区的临床医生咨询委员会，以转介病例。我们将经常咨询他们，为他们的电话提供1-800号码，并访问研究中心，以了解服务更新和导致DILI的重要药物的讨论。2)我们将利用研究者在急性肝衰竭研究中的经验，扩大并鼓励使用DILI生物材料进行进一步的辅助研究。具体的亚组研究应该是可能的，目前在我们的机构正在研究的大量西班牙裔人口。3)我们建议使用N-乙酰半胱氨酸治疗符合Hy齐默尔曼定律（即伴有黄疸的急性疾病）严重损伤标准的DILI病例。