Hepatitis B Research Network Adult Cohort Study

Hepatitis B, a significant cause of cirrhosis and hepatocellular carcinoma worldwide, affects an estimated 800,000 to 1.4 million people in the United States. While progress has been made in the prevention, diagnosis, and treatment of chronic hepatitis B, challenges remain in identifying persons affected by the virus and in determining recommendations for management and treatment. The Hepatitis B Research Network (HBRN) is a multicenter network that was established by the NIDDK to investigate the etiology and progression of the disease and to test the safety and efficacy of current treatment approaches. The HBRN Adult Cohort Study (HBRN Cohort A), one of many studies conducted by the HBRN, was designed to describe participants with hepatitis B virus (HBV) infection and identify predictors of disease activation and progression. The relationship of HBV genotype to clinical, biochemical, and histological characteristics and to pregnancy is also explored.

Individuals of at least 18 years of age who are hepatitis B surface antigen (HBsAg) positive are enrolled in the HBRN Adult Cohort study. Baseline data is collected on demographics, medical history, family history of liver disease, and health behaviors. Participants are categorized into various phases of HBeAg-positive and HBeAg-negative HBV infection and stages of HBV disease for monitoring of changes in HBV infection status and quantitative HBsAg levels. The rate of various clinical outcomes—including hepatitis exacerbation marked by alanine aminotransferase (ALT) flare, antigen loss of HBsAg or HBeAg, cirrhosis, development of hepative decompensation, heptaocellular carcinoma (HCC), death, and liver transplantation—and the factors associated with these outcomes are assessed as primary outcome measures, evaluated at up to 288 weeks. Analyses will be done to determine whether a baseline HBsAg below 1,000 IU/mL and HBV DNA below 1,000 IU/mL are accurate predictors of people who are, or who will become, inactive carriers (defined as people who are HBsAg positive, HBeAg negative, have normal ALT and HBV DNA under 1,000 IU/mL on at least two occasions over a period of at least 6 months with HBV DNA under 1,000 IU/mL). Additionally, biospecimens are collected from participants to create a repository of resources for future studies.

Currently, only data from the baseline visit are available for request.

乙型肝炎（Hepatitis B）是全球范围内肝硬化与肝细胞癌的主要病因，在美国约有80万至140万人受其感染。尽管慢性乙型肝炎的预防、诊断与治疗已取得长足进展，但在识别病毒感染者以及制定规范化管理与治疗方案方面仍存在诸多挑战。乙型肝炎研究网络（Hepatitis B Research Network, HBRN）是由NIDDK发起建立的多中心研究网络，旨在探究该疾病的病因与进展，并评估现有治疗方案的安全性与有效性。HBRN成人队列研究（HBRN Adult Cohort Study，即HBRN Cohort A）是该网络开展的多项研究之一，其研究目的为描述乙型肝炎病毒（Hepatitis B Virus, HBV）感染者的临床特征，并识别疾病激活与进展的预测因子；此外，该研究还将探讨HBV基因型与临床、生化、组织病理学特征以及妊娠的相关性。

本研究招募年满18周岁、乙型肝炎表面抗原（Hepatitis B Surface Antigen, HBsAg）检测呈阳性的个体。研究人员将收集参与者的人口统计学资料、病史、肝病家族史以及健康行为相关基线数据。参与者会被划分为乙型肝炎e抗原（Hepatitis B e Antigen, HBeAg）阳性与HBeAg阴性的HBV感染不同阶段，以及HBV疾病分期，以监测HBV感染状态与定量HBsAg水平的动态变化。多种临床结局的发生速率及相关影响因素将被作为主要结局指标进行评估，随访时长最长可达288周。这些临床结局包括：以丙氨酸氨基转移酶（Alanine Aminotransferase, ALT）升高为特征的肝炎急性发作、HBsAg或HBeAg血清学转阴、肝硬化、肝失代偿、肝细胞癌（Hepatocellular Carcinoma, HCC）、死亡以及肝移植。研究将开展分析，以明确基线HBsAg水平低于1000 IU/mL、HBV DNA低于1000 IU/mL是否可准确预测现已成为或未来将成为非活动性HBV携带者的人群。非活动性HBV携带者的定义为：HBsAg阳性、HBeAg阴性，且至少在6个月内的两次检测中ALT水平正常、HBV DNA低于1000 IU/mL。此外，研究人员还会收集参与者的生物标本，建立生物样本资源库以供未来相关研究使用。

目前仅可申请获取基线访视阶段的研究数据。