Hepatitis Beta Research Network Clinical Center in Pacific Northwest/Alaska

我们建议建立一个临床中心，作为B型肝炎临床研究网络（HB-CRN）的一部分，该网络由华盛顿州和阿拉斯加州的三个合作机构组成。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，儿童医院和区域医疗中心，Harborview医疗中心和退伍军人事务部普吉特海湾医疗保健系统;弗吉尼亚梅森医疗中心;和阿拉斯加土著部落健康联盟，以及一些附属社区和外展诊所。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的HBV感染患者队列，以纳入新治疗药物和方法的自然史研究和临床试验。我们计划建立一个数据库，一个自然史研究，和一个来自太平洋西北部和阿拉斯加的慢性HBV感染患者的生物储存库，包括来自不同种族群体的成人和儿童，包括5种主要的HBV基因型和几种HBV亚型（A1，A2，Ba，Bj，C，D和F）。 我们已经包括了两个潜在研究的建议：（1）自然史研究，以阐明临床、生化和病毒学因素对慢性B型肝炎阶段之间转变的作用;并且，在本发明中，（2）比较替诺福韦/恩曲他滨联合治疗与替诺福韦单药治疗的临床试验（成人）或恩替卡韦（儿童）用于治疗具有免疫活性或免疫耐受性疾病的HBeAg阳性患者。

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.