Hepatitis B Clinical Research Network

乙型肝炎临床研究网络

• 批准号: 7693836
• 负责人: ARUN J SANYAL
• 金额: $ 38.89万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 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/7693836
• 关键词: 2' -fluoro-5-methylarabinosyluracil; Accounting; Address; African American; Antigens; Antiviral Agents; Ascites; Asians; Caucasians; Caucasoid Race; Chronic; Chronic Hepatitis B; Clinical; Clinical Research; Clinical Trials; Conduct Clinical Trials; Data; Databases; Disease; Dose; Enrollment; Epidemiology; Ethnic group; Fibrosis; Hepatitis B; Hepatitis B Virus; Hepatitis C virus; Hepatology; Hospitals; Industry; Infection; Injury; Insulin; Knowledge; Lamivudine; Liver; Liver diseases; Living Donor Liver Transplantation; Medical center; Metabolic syndrome; Minority; Natural History; Newly Diagnosed; Oral; Outcomes Research; Patient Care; Patients; Phase; Physicians; Population; Principal Investigator; Refractory; Research Personnel; Serological; Site; Telbivudine; Tenofovir; Testing; United States National Institutes of Health; Universities; Viral hepatitis; Virginia; adefovir dipivoxil; base; clinical care; cohort; disease natural history; emtricitabine; experience; non-alcoholic fatty liver; nonalcoholic steatohepatitis; patient population; peginterferon alfa-2a; programs; racial and ethnic; response; treatment trial

DESCRIPTION (provided by applicant): To enroll patients from our racially diverse database into various natural history and treatment trials developed by the HBCRN. Our current understanding of the natural history of chronic HBV and the response of this disease to treatment has been dominated by studies conducted in Asian and to a lesser extent Caucasian populations. This may not reflect the natural history of the disease in African Americans. There is a pacuity of data regarding the natural history of chronic HBV and its response to treatment in African Americans. Addressing this gap in our knowledge is important because African Americans represent the second most common racial/ethnic group with chronic HBV infection in the USA. Including Clinical Care Centers with large African American populations in the HBCRN will be critical to understanding the natural history of chronic HBV and its response to treatment in this minority population. African Americans account for approximately 25% of patients with chronic HBV at our Clinical Care Center whereas Asians accounts for less than half of our patients. This unique population will allow the HBCRN to test the following hypotheses: Hypothesis 1: The serologic and virologic spectrum of chronic HBV in African Americans is markedly different than observed in Asians who reside in the USA. Hypothesis 2: Insulin resistence and other features of the metabolic syndrome, which are common in African Americans are associated with more severe liver injury and more rapid fibrosis progression in patients with chronic HBV. Hypothesis 3: African Americans with E-antigen (+) chronic HBV have a significantly lower seroconversion rate following treatment with peginterferon compared to non-African Americans. Hypothesis 4: Insulin resistence and other features of the metabolic syndrome, which are common in African Americans, will reduce virologic response to peginterferon but not to a potent oral antiviral agent.

描述（由申请人提供）：从我们的种族多样性数据库中招募患者进入HBCRN开发的各种自然史和治疗试验。我们目前对慢性HBV的自然史和这种疾病对治疗的反应的理解主要是在亚洲人群中进行的研究，在较小程度上是在高加索人群中进行的研究。这可能不能反映非裔美国人的疾病自然史。关于非裔美国人慢性HBV的自然史及其对治疗的反应，有大量的数据。解决我们知识中的这一差距很重要，因为非洲裔美国人是美国慢性HBV感染第二常见的种族/族裔群体。在HBCRN中纳入有大量非洲裔美国人的临床护理中心对于了解慢性HBV的自然史及其对该少数人群治疗的反应至关重要。在我们的临床护理中心，非裔美国人约占慢性HBV患者的25%，而亚洲人占我们患者的不到一半。这一独特人群将允许HBCRN检验以下假设： 假设1：非裔美国人慢性HBV的血清学和病毒学谱与居住在美国的亚洲人明显不同。 假设二：在非裔美国人中常见的胰岛素抵抗和代谢综合征的其他特征与慢性HBV患者更严重的肝损伤和更快的纤维化进展相关。 假设三：与非非洲裔美国人相比，患有E抗原（+）慢性HBV的非洲裔美国人在聚乙二醇干扰素治疗后的血清转换率显著较低。 假设四：胰岛素抵抗和代谢综合征的其他特征在非裔美国人中很常见，这将减少对聚乙二醇干扰素的病毒学应答，但不会减少对强效口服抗病毒剂的病毒学应答。