CLINICAL TRIAL: HALT-C TRIAL

临床试验：HALT-C 试验

• 批准号: 7719096
• 负责人: HERBERT L BONKOVSKY
• 金额: $ 0.47万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719096
• 关键词: Biopsy; Carcinoma; Chronic Hepatitis C; Cirrhosis; Clinical Trials; Combined Modality Therapy; Computer Retrieval of Information on Scientific Projects Database; Evaluable Disease; Exclusion Criteria; Fibrosis; Funding; Grant; Hepatic; Hepatitis C virus; Histologic; Institution; Interferons; Liver diseases; Monitor; Patients; Phase; Primary carcinoma of the liver cells; Purpose; Quality of life; RNA; Randomized; Randomized Controlled Trials; Research; Research Personnel; Resources; Ribavirin; Risk; Secondary to; Source; United States National Institutes of Health; Virus; Week; improved; interferon therapy; liver transplantation; peginterferon alfa-2a; 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. The purpose of this study is to conduct a randomized, controlled trial to determine if long-term interferon therapy can reasonably reduce the risk of histologic progression to cirrhosis, decompensated liver disease and/or hepatocellular carcinoma in patients with chronic hepatitis C and advanced fibrosis or cirrhosis who failed to respond to previous interferon therapy. Specific aims: 1) To determine if 4 years of interferon therapy will prevent progression of advanced fibrosis to cirrhosis in patients with chronic hepatitis C who failed previous interferon treatment; 2) to determine if 4 years of interferon therapy, in patients with cirrhosis secondary to chronic hepatitis C who failed previous interferon treatment, will a) reduce the risk of developing hepatic decompensation; b) reduce the need for hepatic transplantation; c) reduce the risk of developing hepatoceullar carcinoma; and 3) To determine if 4 years of interferon therapy will improve the quality of life in patients with advanced fibrosis or cirrhosis secondary to chronic hepatitis C who failed previous interferon treatment. Approximately 1200 patients (at all centers) who meet the inclusion/exclusion criteria will be entered into a Lead-in Phase. They will be treated with a combination of Peginterferon alfa-2a and ribavirin for a period of 24 weeks. Patients who have no detectable Hepatitis C Virus (HCV)Ribonucleic Acid (RNA) at week 20 will continue on combination therapy until week 48. Patients who do not clear virus will be randomized 50:50 at week 24 to receive either Peginterferon alfa-2a alone or no further therapy for the next three and a half years. Both randomized groups will be monitored quarterly during these 42 months and biopsies will be obtained at 24 and 48 months after the start of the Lead-in Phase. An estimated 800 patients will be evaluable at the conclusion of the trial.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的目的是进行一项随机对照试验，以确定长期干扰素治疗是否可以合理地降低慢性丙型肝炎和晚期纤维化或肝硬化患者组织学进展为肝硬化，失代偿性肝病和/或肝细胞癌的风险，这些患者对既往干扰素治疗无效。 具体目标：1）确定4年干扰素治疗是否将预防先前干扰素治疗失败的慢性丙型肝炎患者的晚期纤维化进展为肝硬化; 2）确定4年干扰素治疗是否将a）降低先前干扰素治疗失败的慢性丙型肝炎继发性肝硬化患者发生肝失代偿的风险; B）减少肝移植的需要; c）减少发生肝细胞癌的风险;和3）确定4年干扰素治疗是否会改善先前干扰素治疗失败的慢性丙型肝炎继发的晚期纤维化或肝硬化患者的生活质量。 约1200例符合入选/排除标准的患者（所有临床试验机构）将进入导入期。 他们将接受聚乙二醇干扰素α-2a和利巴韦林的联合治疗，为期24周。 第20周时未检出丙型肝炎病毒（HCV）核糖核酸（RNA）的患者将继续接受联合治疗，直至第48周。 未清除病毒的患者将在第24周以50：50的比例随机接受聚乙二醇干扰素α-2a单独治疗或在接下来的三年半内不接受进一步治疗。 在这42个月期间，将每季度对两个随机分组组进行一次监测，并在导入期开始后24个月和48个月进行活检。 在试验结束时，估计有800例患者可供评价。