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资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。这项研究的目的是进行一项随机，对照试验，以确定长期干扰素疗法是否可以合理地降低组织学进展到肝硬化，肝脏疾病的代偿性疾病和/或肝细胞癌对慢性肝炎患者的患者和肝细胞癌的反应，而先前的纤维化或先前的肝硬化患者失败了。 具体目的：1）确定4年的干扰素治疗是否会防止晚期肝炎患者的晚期纤维化向肝硬化的进展； 2）为了确定4年的干扰素治疗，对于先前干扰素治疗失败的慢性肝炎的肝硬化患者，将降低发生肝功能补偿的风险； b）减少对肝移植的需求； c）降低患肝癌癌的风险； 3）为了确定4年的干扰素治疗是否会改善继发于先前干扰素治疗失败的慢性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）将进入铅阶段。它们将通过Peginterferon alfa-2a和Ribavirin的结合进行24周的结合。在第20周没有可检测到的HCV RNA的患者将继续进行联合治疗，直到第48周。没有清楚病毒的患者将在第24周随机分配50:50，以单独接受Peginterferon alfa-2a或在接下来的三年半中接受Peginterferon Alfa-2a或没有进一步的治疗。这两个随机组将在这42个月中进行季度监测，并在启动阶段开始后的24和48个月获得活检。在试验结束时，估计可以评估800名患者。