Hepatitis Beta Research Network Clinical Center in Pacific Northwest/Alaska

我们建议建立一个临床中心，作为由华盛顿州和阿拉斯加州的三个合作机构组成的乙型肝炎临床研究网络（HB-CRN）的一部分。该临床中心汇集了华盛顿大学的患者、研究人员和资源，包括华盛顿大学医学中心、儿童医院和地区医疗中心、港景医疗中心和退伍军人事务普吉特海湾医疗保健系统；弗吉尼亚梅森医疗中心；阿拉斯加土著部落保健联盟以及一些附属社区和外联诊所。我们临床中心参与机构的多样性和范围使我们相信，我们可以在我们地区捕获大量不同种类的hbv感染患者，以纳入自然史研究和新治疗药物和方法的临床试验。我们计划建立一个数据库、一项自然历史研究和来自太平洋西北地区和阿拉斯加的慢性HBV感染患者的生物库，包括来自不同种族的成人和儿童，包括5种主要HBV基因型和几种HBV亚基因型（A1、A2、Ba、Bj、C、D和F）。

We propose to establish a Clinical Center as part of the Hepatitis B Clinical Research Network (HB-CRN) consisting of three collaborating institutions in the states of Washington and Alaska. This Clinical Center brings together the patients, investigators, and resources of the University of Washington, including the University of Washington Medical Center, Children's Hospital and Regional Medical Center, Harborview Medical Center, and the Veterans Affairs Puget Sound Health Care System; Virginia Mason Medical Center; and, the Alaska Native Tribal Health Consortium, as well as a number of affiliated community and outreach clinics. The diversity and scope of our Clinical Center's participating institutions makes us confident that we can capture a large and heterogeneous cohort of HBV-infected patients in our region for inclusion in natural history studies and clinical trials of new therapeutic agents and approaches. We plan to establish a data base, a natural history study, and a biorepository of patients with chronic HBV infection from the Pacific Northwest and Alaska, including both adults and children from a diverse range of ethnic groups and encompassing 5 of the major HBV genotypes and several of the HBV sub-genotypes (A1, A2, Ba, Bj, C, D and F). We have included proposals for two potential studies: (1) a natural history study to elucidate the role of clinical, biochemical, and virologic factors on the transition between phases of chronic hepatitis B; and, (2) a clinical trial comparing combination therapy with tenofovir/emtricitabine versus monotherapy with tenofovir (in adults) or entecavir (in children) for the treatment of HBeAg positive patients with either immune active or immune tolerant disease.