Hepatitis B Clinical Research Network

乙型肝炎临床研究网络

基本信息

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
项目类别：
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&apos -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

项目摘要

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）：将我们的种族多元化数据库中的患者纳入 HBCRN 开发的各种自然史和治疗试验。我们目前对慢性乙型肝炎的自然史以及这种疾病对治疗的反应的了解主要是在亚洲人群中进行的研究，其次是在白人人群中进行的研究。这可能无法反映非裔美国人疾病的自然史。关于非裔美国人慢性乙型肝炎的自然史及其对治疗的反应的数据很少。解决我们的这一知识空白非常重要，因为非裔美国人是美国慢性乙型肝炎感染第二常见的种族/族裔群体。将拥有大量非洲裔美国人的临床护理中心纳入 HBCRN 对于了解慢性乙型肝炎的自然史及其对该少数群体的治疗反应至关重要。在我们的临床护理中心，非裔美国人约占慢性 HBV 患者的 25%，而亚洲人占患者的不到一半。这个独特的群体将使 HBCRN 能够检验以下假设：假设 1：非洲裔美国人的慢性 HBV 血清学和病毒学谱与居住在美国的亚洲人明显不同。假设 2：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乙型肝炎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化率显着较低。假设 4：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会降低对聚乙二醇干扰素的病毒学反应，但不会降低对强效口服抗病毒药物的病毒学反应。