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: 7932256
• 负责人: William M Lee
• 金额: $ 49.66万
• 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/7932256
• 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; 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; 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）：乙型肝炎病毒感染仍然是慢性肝病和肝癌的重要原因，影响着大约 200 万美国人和全球超过 3.5 亿人。尽管发现了疫苗，但慢性、往往是终生乙型肝炎感染的负担在我国仍然很高，在国外更是如此。人们对其自然史和发病机制的了解有所提高，但这种复杂感染的许多方面仍然有待我们理解。例如，免疫系统在造成肝损伤和消除感染方面都发挥着重要作用，但迄今为止增强免疫反应以改善病毒清除的努力都失败了。现在可以使用核苷类似物来降低病毒负荷，从而改善肝脏炎症，但突变频繁出现，药物在治疗不同阶段乙型肝炎患者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并不知道自己患有这种疾病，也不知道在大多数情况下治疗会带来明显的好处。需要在患者和医生教育方面做出新的努力，以惠及许多感染并可以从护理中受益的患者。在美国，大约 50% 的慢性乙型肝炎患者是亚洲人，尽管 ALT 值落在标准参考范围内，但其中许多患者患有需要治疗的疾病 - 可能需要对该组进行治疗，但迄今为止尚未在任何对照试验中进行尝试。目前的 RFA 旨在应对这些挑战。我们的提案回顾了当前有关乙型肝炎的知识，提供了达拉斯沃斯堡大都市乙型肝炎负担的数据，以及研究人员未来为拟议研究招募工作的优势和经验。我们还提供了详细数据库的具体试验设计概要，并回答了人们提出的问题，即转氨酶正常水平较高的活跃病毒血症亚裔美国人在多大程度上受益于强效、低耐药核苷类似物的长期治疗。