Clinical and Epidemiology Core

临床和流行病学核心

基本信息

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
项目类别：
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

项目摘要

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）治疗性抗病毒方案的不断改善，并且随着病毒的益处根除变得更加明显，增加治疗成功率的需求越来越多重要的。护理标准（SOC）治疗方案，包括pe节制干扰素（PEG-IFN）和利巴韦林是冗长的，具有重大的副作用，并且不能使所有患者受益。重新完成阶段 2个试验表明，新药物的疗效提高了，例如HCV蛋白酶抑制剂和聚合酶抑制剂。第三阶段的试验已不复存在，很快可能会批准新的联合疗法，包括蛋白酶抑制剂telaprevir或Boceprevir与PEG-IFN和利巴韦林。尽管有这些最近的进步，但仍需了解基本的不足人类免疫反应对HCV的无效的机制，既可以最大化当前的好处可用的治疗方法，并为开发更有效疗法所必需的知识基础做出贡献。临床流行病学核心的使命是支持和促进中心的两个综合关于先天和适应性免疫的研究项目。核心将（a）从2005-2009年，从2005年的2009年中，识别，招募和获取200例具有回顾性定义的PEG-IFN/Ribavirin治疗结果的患者的血液样本，用于HCV基因型1（GT-1）；（b）在2011 - 2014年间，从80名接受治疗的患者组成的多样化的治疗患者中，招募并获得连续的血液样本，该治疗疗法启动了HCV GT-1的组合抗病毒疗法；（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以及对人类受试者的各个方面的管理。简而言之，核心将开发和维护该中心的生物座席和全面的研究数据库，并为（a）为中心项目开发分析数据库，并提供（a）进行流行病学，生物统计学和数据分析专业知识，以及（b）进行抗病毒治疗反应免疫学相关性的内部和预测分析。