Clinical and Epidemiology Core

临床和流行病学核心

• 批准号: 7919831
• 负责人: NORAH A. TERRAULT
• 金额: $ 35.23万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-15 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7919831
• 关键词: Adverse effects; Antiviral Agents; Antiviral Therapy; Area; Blood specimen; Caring; Chronic Hepatitis C; Clinical; Clinical Research; Combined Modality Therapy; Data Analyses; Databases; Development; Enrollment; Epidemiology; Genotype; Goals; Hepatitis C; Hepatitis C virus; Hepatology; Human; Immune response; Immune system; Immunologic Factors; Immunology; Interferons; Laboratories; Laboratory Research; Maintenance; Mission; New Agents; Outcome; Participant; Patients; Pharmaceutical Preparations; Phase II Clinical Trials; Phase III Clinical Trials; Polymerase; Process; Protease Inhibitor; Protocols documentation; Regimen; Research; Research Personnel; Research Project Grants; Ribavirin; Specimen; Therapeutic; Time Study; Treatment Protocols; Viral; adaptive immunity; biobank; clinical epidemiology; cohort; design; effective therapy; human subject; human subject protection; improved; inhibitor/antagonist; knowledge base; programs; prospective; response; success; treatment response

As hepatitis C virus (HCV) therapeutic antiviral regimens continue to improve and as the benefits of viral eradication become more apparent, the need to increase treatment success rates becomes ever more important. Standard-of-care (SOC) treatment regimens that include pegylated interferon (peg-IFN) and ribavirin are lengthy, have significant side effects, and do not benefit all patients. Recenfiy completed phase 2 trials have demonstrated improved efficacy of new agents, such as HCV protease inhibitors and polymerase inhibitors. Phase 3 trials are undenway and there may soon be FDA approval of new combinafion therapies, including the protease inhibitors telaprevir or boceprevir combined with peg-IFN and ribavirin. Despite these recent advances, there remains'an underiying need to understand the fundamental mechanisms of the human immune response to HCV infecfion, both to maximize the benefits of currently available treatments and to contribute to the knowledge base necessary to develop more effective therapies. The mission of the Clinical Epidemiology Core is to support and facilitate the Center's two integrated research Projects on innate and adaptive immunity. The Core will (a) identify, enroll, and obtain a blood sample from a diverse group of 200 patients with retrospectively defined outcomes of peg-IFN/ribavirin treatment in the years 2005-2009 for HCV genotype 1 (GT-1); (b) enroll and obtain consecutive blood samples from a diverse prospective cohort of 80 treatment-naive patients initiating combination antiviral therapy for HCV GT-1 in the years 2011-2014; and (c) provide hepatology and clinical research expertise to the Center's overall goals, including the development of patient-related protocols and the administration of all aspects of human subjects protecfion. In addifion, the Core will develop and maintain the Center's biorepository and comprehensive study databases and provide epidemiological, biostatistical, and data analysis expertise to (a) develop analytic databases for the Center's projects and (b) conduct the intra- and inter-project analyses of the immunological correlates of antiviral treatment responses.

随着丙型肝炎病毒 (HCV) 治疗抗病毒方案的不断改进以及病毒治疗的益处 根除变得更加明显，提高治疗成功率的必要性变得越来越大 重要的。标准护理 (SOC) 治疗方案包括聚乙二醇干扰素 (peg-IFN) 和 利巴韦林疗程较长，副作用显着，且并不能使所有患者受益。 Recenfiy完成阶段 2 项试验证明新药的疗效有所改善，例如 HCV 蛋白酶抑制剂和 聚合酶抑制剂。第三阶段试验正在进行中，新药可能很快就会获得 FDA 批准 联合疗法，包括蛋白酶抑制剂特拉匹韦或博普匹韦联合聚乙二醇干扰素和 利巴韦林。尽管最近取得了这些进展，但仍然迫切需要了解基本原理 人类对丙型肝炎病毒感染的免疫反应机制，既可以最大限度地利用目前的益处 现有的治疗方法，并为开发更有效的治疗方法所需的知识库做出贡献。 临床流行病学核心的使命是支持和促进该中心的两个综合 先天性和适应性免疫的研究项目。核心将 (a) 识别、登记并获取 200 名不同患者组的血液样本，这些患者回顾性地确定了 2005 年至 2009 年期间针对 HCV 基因型 1 (GT-1) 的聚乙二醇干扰素/利巴韦林治疗的结果； (b) 从 2011 年至 2014 年期间开始 HCV GT-1 联合抗病毒治疗的 80 名初治患者组成的不同前瞻性队列中登记并获得连续的血液样本； (c) 为中心的总体目标提供肝病学和临床研究专业知识，包括制定与患者相关的方案和管理人类受试者保护的各个方面。此外，核心将开发和维护中心的生物样本库和综合研究数据库，并提供流行病学、生物统计和数据分析专业知识，以（a）为中心的项目开发分析数据库，以及（b）对抗病毒治疗反应的免疫相关性进行项目内和项目间分析。