Hepatitis B Clinical Research Network

乙型肝炎临床研究网络

基本信息

批准号：
8545816
负责人：
RICHARD K. STERLING
金额：
$ 32.03万
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/8545816
关键词：
2&apos -fluoro-5-methylarabinosyluracil Accounting Address African American 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 Insulin Knowledge Lamivudine 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 liver injury non-alcoholic fatty liver nonalcoholic steatohepatitis patient population peginterferon alfa-2a programs racial and ethnic response treatment trial

2&apos -fluoro-5-methylarabinosyluracil Accounting Address African American 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 Insulin Knowledge Lamivudine 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 liver injury non-alcoholic fatty liver nonalcoholic steatohepatitis patient population peginterferon alfa-2a programs racial and ethnic response treatment trial

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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）：将来自种族多样化数据库的患者招募到HBCRN开发的各种自然病史和治疗试验中。我们目前对慢性HBV的自然史以及该疾病对治疗的反应的理解是在亚洲和较小程度的高加索人群中所做的。这可能不能反映非裔美国人疾病的自然史。关于慢性HBV的自然史及其对非裔美国人治疗的反应有很多数据。在我们的知识中解决这一差距很重要，因为非裔美国人代表了美国第二常见的种族/族裔群体，在美国慢性HBV感染。在HBCRN中，包括临床护理中心，对于了解慢性HBV的自然历史及其对少数族裔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HBV患者的25％，而亚洲人占我们患者的一半。这种独特的人群将使HBCRN能够检验以下假设：假设1：非裔美国人慢性HBV的血清学和病毒学谱与在美国居住的亚洲人中观察到的明显不同。假设2：胰岛素抵抗和代谢综合征的其他特征，在非洲裔美国人中很常见，与慢性HBV患者的肝损伤更为严重，纤维化进展更快。假设3：与非非洲美国人相比，使用E-抗原（+）慢性HBV的非洲裔美国人的血清转化率明显降低。假设4：在非洲裔美国人中常见的代谢综合征的胰岛素抵抗和其他特征将减少对Peginterferon的病毒学反应，但对有效的口服抗病毒剂的反应不会减少。