North Texas Hepatitis B Consortium: Clinical Site for the Hepatitis B Network

北德克萨斯乙型肝炎联盟：乙型肝炎网络的临床站点

• 批准号: 8330285
• 负责人: William M Lee
• 金额: $ 14.69万
• 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 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8330285
• 关键词: Academic Medical Centers; Affect; African American; American; Asian Americans; Asians; Attention; Awareness; Caring; Chronic; Chronic Hepatitis B; Cities; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Communities; Complex; Conduct Clinical Trials; Country; DNA; Data; Databases; Diagnosis; Disease; Disease Progression; Drug resistance; Economics; Education; Environment; Ethnic Origin; Future; Gastroenterology; Goals; Health; Hepatitis B; Hepatitis B Therapy; Hispanics; Immune response; Immune system; Infection; Inflammation; Inflammatory; Institution; Knowledge; Learning; Link; Liver; Liver diseases; Lymphocyte; Malignant neoplasm of liver; Molecular; Mutation; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; Observational Study; Outcome; Pathogenesis; Patients; Pharmaceutical Preparations; Phase; Physicians; Plasma; Play; Recruitment Activity; Reference Values; Research; Research Personnel; Resistance; Role; Sampling; Serum; Site; Specialist; Texas; Transaminases; Treatment Protocols; United States; Vaccines; Viral; Viral Load result; Virus Diseases; advanced disease; base; chronic liver disease; clinical research site; control trial; experience; falls; improved; meetings; nucleoside analog; repository; standard care; suburb

DESCRIPTION (provided by applicant): Hepatitis B viral infection remains an important cause of chronic liver disease and liver cancer, affecting approximately 2 million Americans and more than 350 million people worldwide. Despite vaccine discovery, the burden of chronic, often lifelong hepatitis B infection remains high in this country and even more so abroad. Understanding its natural history and pathogenesis has improved but there are still many aspects of this complex infection that escape our understanding. For example, the immune system plays an important role both in causing liver damage and in its eradicating infection, but efforts thus far to heighten immune responses to improve viral clearance have failed. Nucleoside analogues are now available that are capable of lowering the viral burden, with resultant improvement in inflammation in the liver, but mutations arise frequently and the role of drugs in the management of patients with various phases of hepatitis B remains controversial. In addition, many patients with serious underlying liver disease are unaware of their disease or the clear benefits of treatment that accrue in most circumstances. New efforts at patient and physician education will be needed to reach the many patients who have infection and could benefit from care. Approximately 50% of patients with chronic hepatitis B in the US are of Asian ethnicity and many of these patients have disease that warrants treatment despite ALT values that fall within the standard reference range-treatment of this group is probably indicated but has not been tried in any controlled trial to date. The present RFA is intended to meet these challenges. Our proposal reviews current knowledge about hepatitis B, provides data on the burden of hepatitis B in the Dallas Fort Worth metroplex, and the strengths and experience of the investigators for future recruiting efforts for the proposed studies. We also provide the outline of a specific trial designs for a detailed database and to answer the concern raised, that is, to what extent do actively viremic Asian Americans with high normal aminotransferase levels benefit from a prolonged course of treatment with a potent, low resistance nucleoside analog.

描述（由申请人提供）：丙型肝炎病毒感染仍然是慢性肝病和肝癌的重要原因，影响了全球约200万美国人，超过3.5亿人。尽管发现了疫苗，但在这个国家，慢性，终生肝炎的负担仍然很高，在国外更加如此。了解其自然史和发病机理已经有所改善，但这种复杂的感染仍有许多方面避免了我们的理解。例如，免疫系统在造成肝脏损害和根除感染方面起着重要作用，但是迄今为止，为提高免疫反应以提高病毒清除率而努力失败了。现在可以使用核苷类似物，能够降低病毒负担，从而改善肝脏的炎症，但是突变经常出现，药物在乙型肝炎各个阶段的患者管理中的作用仍然存在争议。此外，许多患有严重潜在肝病的患者没有意识到自己的疾病或在大多数情况下会产生的明显治疗益处。需要在患者和医师教育方面进行新的努力，以吸引许多感染并可以从护理中受益的患者。在美国，大约50％的慢性丙型肝炎患者是亚洲种族，其中许多患者患有疾病，尽管ALT值属于该组的标准参考范围处理，但仍可能表明，但迄今尚未在任何受控试验中尝试过。目前的RFA旨在应对这些挑战。我们的提案回顾了有关乙型肝炎的当前知识，提供了有关达拉斯堡沃思堡Metroplex中丙型肝炎负担的数据，以及研究人员的优势和经验，以供未来的招聘工作进行拟议的研究。我们还为详细数据库提供了特定试验设计的轮廓，并回答提出的关注点，也就是说，具有高正常氨基反转移酶水平的高广泛性亚裔美国人在多大程度上受益于长时间的治疗，并具有有效的，低抗性的核苷类似物。