HEPATITIS C ANTIVIRAL LONG-TERM TREATMENT TO PREVENT CIRRHOSIS (HALT-C)

丙型肝炎抗病毒长期治疗以预防肝硬化 (HALT-C)

• 批准号: 7604371
• 负责人: Gregory Thomas Everson
• 金额: $ 15.15万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604371
• 关键词: Adverse effects; Affect; Antiviral Agents; Blood; Blood specimen; Chronic Hepatitis C; Cirrhosis; Clinic Visits; Coin; Computer Retrieval of Information on Scientific Projects Database; Enrollment; Esophagus; Funding; Grant; Hemorrhage; Hepatitis; Hepatitis C; Injection of therapeutic agent; Institution; Interferons; Maintenance; Maintenance Therapy; Malignant neoplasm of liver; Patients; Pharmaceutical Preparations; Phase; Procedures; Quality of life; Questionnaires; Recording of previous events; Research; Research Personnel; Resources; Ribavirin; Risk; Screening procedure; Source; Standards of Weights and Measures; Stomach; Stream; United States; United States Food and Drug Administration; United States National Institutes of Health; Varicosity; Veins; Viral; Visit; Week; follow-up; liver biopsy; prevent

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hepatitis C affects about 4 million people in the United States and leads to cirrhosis and liver cancer after many years, in some patients. Treatment with interferon, alone or in combination with a second anti-viral agent ribavirin has been approved by the Food and Drug Administration and is now considered standard therapy for chronic hepatitis C. A slow release form of interferon, called PEG-interferon, remains in the blood stream for one week and gives better results than interferon alone, with fewer injections required. The present study is aimed at patients who have received previous treatment and failed to clear hepatitis C. Patients who meet entry criteria, and are enrolled in the trial, will first be treated with the combination of PEG Interferon plus ribavirin. Responders to this treatment will be given a full one year of therapy. Nonresponders, after 24 weeks of the combination treatment, will be entered into the study of maintenance therapy. Nonresponders will be evenly assigned (by a procedure similar to the toss of a coin) to either maintenance with PEG Interferon (treatment) or no treatment (observation). Follow-up will be identical for the treatment and observation groups and will require 3-monthly visits for 3 1/2 years with 6 months follow-up. Each visit will include history, exam, quality-of-life questionnaire, and blood drawing. Liver biopsies will be performed at two and four years following start of the initial phase. Some patients will undergo endoscopic examination of the esophagus and stomach for varices, large veins at risk for bleed. Risks encountered may include side effects of study medications, that involved in obtaining blood samples, and that of liver biopsy at year 2 and at end of study. Patients will be required to attend two screening visits, plus clinic visits at routine intervals over the entire course of the study.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 丙型肝炎影响着美国约 400 万人，部分患者多年后会导致肝硬化和肝癌。 单独使用干扰素或与另一种抗病毒药物利巴韦林联合使用的干扰素治疗已获得美国食品和药物管理局的批准，目前被认为是慢性丙型肝炎的标准治疗方法。一种称为 PEG 干扰素的缓慢释放形式的干扰素仍然存在血流持续一周，比单独使用干扰素效果更好，且所需注射次数更少。 本研究针对的是既往接受过治疗但未能清除丙型肝炎的患者。符合入组标准并参加试验的患者将首先接受聚乙二醇干扰素加利巴韦林的联合治疗。 对这种治疗有反应的人将接受整整一年的治疗。 无反应者在联合治疗24周后将进入维持治疗研究。 无反应者将被平均分配（通过类似于抛硬币的程序）接受 PEG 干扰素维持治疗（治疗）或不接受治疗（观察）。 治疗组和观察组的随访将相同，并且需要在 3 1/2 年中每 3 个月进行一次随访，并进行 6 个月的随访。 每次就诊将包括病史、检查、生活质量调查问卷和抽血。 肝脏活检将在初始阶段开始后的两年和四年内进行。 有些患者会接受食道和胃的内窥镜检查，检查是否有静脉曲张，即有出血风险的大静脉。 遇到的风险可能包括研究药物的副作用、涉及获取血液样本的副作用，以及第 2 年和研究结束时的肝活检的副作用。 患者将被要求参加两次筛查访问，并在整个研究过程中定期进行临床访问。