Hepatitis B Clinical Research Network

乙型肝炎临床研究网络

• 批准号: 7932257
• 负责人: RICHARD K. STERLING
• 金额: $ 33.64万
• 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/7932257
• 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)：将我们种族多样性数据库中的患者纳入HBCRN开发的各种自然病史和治疗试验。我们目前对慢性乙肝的自然病史和这种疾病对治疗的反应的了解主要是在亚洲人和较少程度的高加索人群体中进行的研究。这可能不能反映这种疾病在非裔美国人中的自然病史。关于非裔美国人慢性乙肝的自然病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，因为非裔美国人是美国第二大最常见的慢性乙肝病毒感染的种族/民族群体。在HBCRN中包括拥有大量非裔美国人的临床护理中心，将对了解慢性乙肝的自然历史及其在这一少数群体中对治疗的反应至关重要。在我们的临床护理中心，非洲裔美国人约占慢性乙肝患者的25%，而亚洲人占我们患者的不到一半。这一独特的群体将使HBCRN能够测试以下假设： 假设1：非洲裔美国人的慢性乙肝的血清学和病毒学图谱与居住在美国的亚洲人明显不同。 假设2：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，与慢性乙肝患者更严重的肝损伤和更快的纤维化进展有关。 假设3：与非非洲裔美国人相比，患有E抗原(+)慢性乙肝病毒的非洲裔美国人在接受聚乙二醇干扰素治疗后的血清转换率显著较低。 假设4：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，会降低对聚乙二醇干扰素的病毒学反应，但不会降低对有效的口服抗病毒药物的反应。