HALT-C TRIAL

HALT-C 试验

• 批准号: 7377318
• 负责人: HERBERT L BONKOVSKY
• 金额: $ 2.37万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7377318
• 关键词: HALT; TRIAL

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，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降低对既往干扰素治疗无反应的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。 具体目标： 1) 确定 4 年的干扰素治疗是否能够预防既往干扰素治疗失败的慢性丙型肝炎患者晚期纤维化进展为肝硬化； 2) 确定对于既往干扰素治疗失败的慢性丙型肝炎继发性肝硬化患者，为期 4 年的干扰素治疗是否会 a) 降低发生肝代偿失调的风险； b) 减少肝移植的需要； c) 降低发生肝细胞癌的风险； 3) 确定 4 年的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。 大约 1200 名符合纳入/排除标准的患者（所有中心）将进入导入阶段。他们将接受聚乙二醇干扰素 alfa-2a 和利巴韦林联合治疗，为期 24 周。在第 20 周未检测到 HCV 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 的比例随机分配，接受单独的聚乙二醇干扰素 alfa-2a 治疗或在接下来的三年半内不再接受进一步治疗。在这 42 个月内，将每季度对两个随机组进行监测，并在导入阶段开始后的 24 个月和 48 个月时进行活检。试验结束时估计将有 800 名患者接受评估。