CLINICAL TRIAL: HALT-C TRIAL

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项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对以前的干扰素治疗无效的慢性丙型肝炎和晚期纤维化或肝硬变患者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4年的干扰素治疗是否可以防止先前干扰素治疗失败的慢性丙型肝炎患者的晚期纤维化发展为肝硬变；2)确定对于先前干扰素治疗失败的慢性丙型肝炎继发性肝炎患者，4年的干扰素治疗是否将a)降低发生肝脏失代偿的风险；b)减少肝移植的需要；c)降低发展为肝细胞癌的风险；以及3)确定4年的干扰素治疗是否将改善先前干扰素治疗失败的慢性丙型肝炎继发于慢性丙型肝炎的晚期纤维化或肝硬化患者的生活质量。 符合纳入/排除标准的大约1200名患者(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周没有检测到丙型肝炎病毒(HCV)核糖核酸(RNA)的患者将继续接受联合治疗，直到第48周。未清除病毒的患者将在第24周被随机分为50：50，要么单独接受聚乙二醇α-2a干扰素治疗，要么在接下来的三年半内不再接受进一步治疗。这两个随机分组将在这42个月内每季度监测一次，并将在引入阶段开始后24个月和48个月获得活组织检查。在试验结束时，估计有800名患者可以进行评估。

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 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.