HALT-C TRIAL

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。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既往干扰素治疗无效的组织学进展为肝硬化、失代偿性肝病和/或肝细胞癌的风险。具体目的：1)确定干扰素治疗4年是否能防止先前干扰素治疗失败的慢性丙型肝炎患者进展为晚期纤维化到肝硬化；2)确定干扰素治疗失败的慢性丙型肝炎继发肝硬化患者4年干扰素治疗是否会降低发生肝功能失代偿的风险；B)减少肝移植的需要；C)降低发生肝癌的风险；3)确定干扰素治疗4年是否会改善先前干扰素治疗失败的晚期纤维化或慢性丙型肝炎继发肝硬化患者的生活质量。大约1200名符合纳入/排除标准的患者（在所有中心）将进入先导阶段。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。在第20周未检测到HCV RNA的患者将继续联合治疗至第48周。未清除病毒的患者将在第24周以50:50的比例随机分配，要么单独接受聚乙二醇干扰素α -2a治疗，要么在未来三年半内不再接受进一步治疗。在这42个月期间，将每季度监测两个随机分组，并在导入阶段开始后的24个月和48个月进行活检。在试验结束时，估计将对800名患者进行评估。

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 HCV 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.