Hepatitis B Clinical Research Network Clinical Center: Michigan - Hawaii Consortium

乙型肝炎临床研究网络临床中心：密歇根-夏威夷联盟

• 批准号: 9133357
• 负责人: ANNA S.F. LOK
• 金额: $ 23.9万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 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 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9133357
• 关键词: 18 year old; Acute; Acute Hepatitis; Address; Adult; Ancillary Study; Antibodies; Antiviral Therapy; Asians; Behavior; Canada; Censuses; Child; Childhood; Chronic Hepatitis B; Clinical; Clinical Immunology; Clinical Research; Clinical Trials; Clinical Trials Network; Cohort Studies; Collaborations; Collection; Combined Modality Therapy; Conduct Clinical Trials; Consensus; Country; Data; Data Analyses; Data Coordinating Center; Development; Disease; Enrollment; Epidemiologic Factors; Epidemiology; Epitopes; Flare; Funding; Genomics; Goals; HBV Genotype; HIV; Hawaii; Health; Hepatic; Hepatitis; Hepatitis B; Hepatitis B Prevalence; Hepatitis B Surface Antigens; Hepatitis B Therapy; Hepatitis B Vaccines; Hepatitis B Virus; Hepatitis B e Antigens; Hepatitis D; High Prevalence; Home environment; Immigrant; Immune; Immunologics; Immunology; Imprisonment; Incidence; Infection; Interferon-alpha; Interferons; Leadership; Life Style; Liver diseases; Manuscripts; Medical center; Michigan; National Health and Nutrition Examination Survey; Natural History; North America; Outcome; Pacific Island Americans; Participant; Pathogenesis; Patient Representative; Patients; Pattern; Persons; Phase; Phenotype; Play; Policies; Pregnancy; Prevalence; Primary carcinoma of the liver cells; Protocols documentation; Public Health; Quality of life; Research; Research Design; Research Personnel; Research Priority; Safety; Sampling; Serotyping; Site; Staging; Surface; Tenofovir; Therapeutic immunosuppression; Treatment Efficacy; United States; United States National Institutes of Health; Universal Precautions; Universities; Variant; Virus Diseases; Virus Replication; Withdrawal; abstracting; base; clinical phenotype; clinically relevant; clinically significant; co-infection; cohort; design; entecavir; high risk; improved; industry partner; liver transplantation; peginterferon alfa-2a; pilot trial; randomized trial; repository; response; seroconversion; symposium; treatment response; trial comparing; virology

 DESCRIPTION (provided by applicant): Hepatitis B virus (HBV) infection remains a major public health problem in the United States (US) with an estimate of up to 2.2 million persons chronically infected. The Hepatitis B Research Network (HBRN) was established in 2008 to address the research priorities identified at the 2008 NIH Consensus Conference on Hepatitis B. The HBRN comprises 13 clinical consortia (21 adult and 7 pediatric clinical centers) in the US and in Toronto, Canada, a data coordinating center, and an immunology center. During the initial funding cycle of HBRN, the investigators developed and implemented an observational cohort study, a clinical trial for patients in the immune tolerant phase and a clinical trial for patients in the immune active phase of HBV infection. This Clinical Center application comprises 2 sites: University of Michigan in Ann Arbor (PI: Dr. Lok) and University of Hawaii/Queen's Medical Center in Honolulu (PI: Dr. Tsai). The Michigan-Hawaii (MI-HI) team has made important contributions to the HBRN studies through enrollment and retention of patients, and data and biospecimen collection. Furthermore, we have played a key role in designing the study protocols and data forms, serving and chairing on HBRN committees, and drafting and editing abstracts and manuscripts. As Chair of the HBRN Steering Committee and Executive Committee since its inception, Dr. Lok has provided leadership in the design and execution of scientific studies, establishing policies for HBRN, and setting up collaboration with industry partners. The specific aims of the MI-HI consortium in the next funding cycle of HBRN are: 1) to continue to enroll patients into HBRN studies and to follow those who have been enrolled to study completion; 2) to contribute to the development of new study proposals making use of data and biospecimens that are collected to further our understanding of the epidemiology, natural history, pathogenesis, and treatment of hepatitis B; and 3) to participate in data analyses and dissemination through abstract presentations and manuscripts. The ancillary study we propose aims to determine: 1) prevalence of co-existent HBsAg and anti- HBs; 2) associating epidemiologic factors; 3) clinical significance; 4) quantitative HBsAg levels and correlation with anti-HBs levels; 5) prevalence of immune escape variants and mixed HBV genotypes/serotypes; and 6) epitope recognition and neutralizing ability of circulating anti-HBs in HBRN participants (adults and children) with co-existent HBsAg and anti-HBs.

 描述（由申请人提供）：乙型肝炎病毒 (HBV) 感染仍然是美国 (US) 的一个主要公共卫生问题，估计有多达 220 万人被慢性感染。乙型肝炎研究网络 (HBRN) 成立于 2008 年，旨在解决 2008 年 NIH 乙型肝炎共识会议确定的研究重点。HBRN 由位于美国和加拿大多伦多的 13 个临床联盟（21 个成人和 7 个儿科临床中心）、一个数据协调中心和一个免疫学中心组成。在 HBRN 的初始资助周期中，研究人员开发并实施了一项观察性队列研究、一项针对乙肝病毒感染免疫耐受期患者的临床试验和一项针对乙肝病毒感染免疫活跃期患者的临床试验。该临床中心应用程序包括 2 个地点：安娜堡的密歇根大学（PI：Lok 博士）和檀香山的夏威夷大学/皇后医疗中心（PI：Tsai 博士）。密歇根-夏威夷 (MI-HI) 团队通过患者入组和保留以及数据和生物样本收集，为 HBRN 研究做出了重要贡献。此外，我们在设计研究方案和数据表格、担任 HBRN 委员会的服务和主席以及起草和编辑摘要和手稿方面发挥了关键作用。自 HBRN 成立以来，作为 HBRN 指导委员会和执行委员会的主席，Lok 博士在科学研究的设计和执行、制定 HBRN 政策以及与行业合作伙伴建立合作方面发挥了领导作用。 MI-HI 联盟在 HBRN 下一个资助周期的具体目标是： 1) 继续招募患者参加 HBRN 研究并跟踪已招募患者直至研究完成； 2) 利用收集到的数据和生物样本，促进新研究提案的制定，以进一步了解乙型肝炎的流行病学、自然史、发病机制和治疗； 3）参与数据分析 并通过摘要演示和手稿进行​​传播。我们提出的辅助研究旨在确定： 1) HBsAg 和抗 HBs 共存的患病率； 2）关联流行病学因素； 3）临床意义； 4) 定量HBsAg水平及其与抗HBs水平的相关性； 5) 免疫逃逸变异和混合 HBV 基因型/血清型的流行； 6) HBsAg 和抗 HBs 共存的 HBRN 参与者（成人和儿童）循环抗 HBs 的表位识别和中和能力。