HEP C ANTIVIRAL LONG-TERM TREATMENT AGAINST CIRRHOSIS (HALT-C) TRIAL

HEP C 抗病毒长期治疗肝硬化 (HALT-C) 试验

• 批准号: 7375118
• 负责人: Mitchell L Shiffman
• 金额: $ 23.81万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375118
• 关键词: HEP; ANTIVIRAL; LONG; TERM; TREATMENT

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. A determination of the effectiveness of long-term antiviral therapy for chronic hepatitis C (HALT-C) with long-term peginterferon alfa-2a in patients who failed to respond to previous interferon therapy. Chronic hepatitis C, an illness caused by the hepatitis C virus (HCV), affects four million patients in the United States, and results in 10,000 deaths annually. Hepatitis C is the most common cause of liver transplantation and is a major predisposing factor to the development of liver cancer in the U.S.A. Also, hepatitis C produces debilitating fatigue in 12% of patients and a variety of other non-liver problems. This study will try to determine if long-term treatment with interferon can safely prevent the progression of advanced fibrosis to cirrhosis in patients with hepatitis C who failed to respond to previous interferon therapy. It will determine if the risk of developing hepatic decompensation and the risk of developing hepatocellular carcinoma are reduced. During this four year treatment program, the specific aims will be to reduce the risk of developing hepatic decompensation, to reduce the need for transplantation, and to reduce the risk of developing liver cancer. Also, it will be determined if the four 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 therapy. The study will include 165 adults with documented non-response to the most recent course of interferon. During a screening visit, histories, physical examinations, and blood tests will be done. A questionnaire about drug use, alcohol use, and mental state will be given. A second screening visit for patients who pass the first will consist of the completion of the questionnaire, signing of the consent form, a urinalysis, a liver biopsy, and an ultrasound of the liver. At least eight weeks later, there will be a baseline visit. All patients will be treated with peginterferon alfa-2a once a week alone, or with ribavirin given in two daily doses. Doses are prescribed according to weight. Weeks 2-20, regular CRC visits will take place. At week 20, several tests will be given which will be assessed during weeks 20-24. Patients who have virologic responses at week 20 will be treated through week 48 and followed-up through week 72. ,

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。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。对既往干扰素治疗无效的慢性丙型肝炎（HALT-C）患者进行长期抗病毒治疗联合长期聚乙二醇干扰素α-2a的有效性测定 慢性丙型肝炎是由丙型肝炎病毒（HCV）引起的疾病，在美国影响400万患者，每年导致10，000人死亡。丙型肝炎是肝移植最常见的原因，也是美国肝癌发展的主要诱发因素。此外，丙型肝炎在12%的患者中产生衰弱性疲劳和各种其他非肝脏问题。 本研究将试图确定干扰素长期治疗是否可以安全地预防对既往干扰素治疗无效的丙型肝炎患者的晚期纤维化进展为肝硬化。它将确定发生肝脏失代偿的风险和发生肝细胞癌的风险是否降低。 在这个为期四年的治疗计划中，具体目标将是降低发生肝功能失代偿的风险，减少移植的需要，并降低发生肝癌的风险。此外，还将确定四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。 该研究将包括165名对最近的干扰素疗程无应答的成年人。在筛选访视期间，将进行病史、体格检查和血液检查。将提供一份关于药物使用、酒精使用和精神状态的问卷。通过第一次筛选访视的患者的第二次筛选访视将包括完成问卷、签署知情同意书、尿液分析、肝活检和肝脏超声检查。 至少8周后，将进行基线访视。所有患者将接受聚乙二醇干扰素α-2a治疗，每周一次，或与利巴韦林给予每日两次剂量。剂量根据体重规定。第2-20周，将进行定期CRC访视。在第20周，将进行几项测试，并在第20-24周进行评估。在第20周有病毒学应答的患者将接受治疗至第48周，并随访至第72周。 ,