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

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。 长期使用聚乙二醇型干扰素α-2a治疗慢性丙型肝炎(HALT-C)对先前干扰素治疗无效的患者的疗效测定。 慢性丙型肝炎是由丙型肝炎病毒(丙型肝炎病毒)引起的一种疾病，在美国影响着400万患者，每年导致1万人死亡。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因。此外，丙型肝炎会使12%的患者产生衰弱乏力和各种其他非肝脏问题。 这项研究将试图确定干扰素的长期治疗是否可以安全地防止先前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变。它将确定发生肝脏失代偿的风险和发展为肝细胞癌的风险是否降低。 在这四年的治疗计划中，具体目标将是降低发生肝脏失代偿的风险，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于晚期纤维化或肝硬变的患者的生活质量。 这项研究将包括165名有记录的成年人，他们对最近的干扰素疗程没有反应。在筛查访问期间，将进行病史、体检和血液测试。将给出一份关于药物使用、酒精使用和精神状态的问卷。通过第一次筛查的患者将进行第二次筛查，包括填写问卷、签署同意书、尿检、肝脏活检和肝脏超声波检查。 至少8周后，将进行基线访问。所有患者都将单独接受一周一次的聚乙二醇α-2a干扰素治疗，或每天两次服用利巴韦林。剂量是根据体重来定的。第2-20周，将进行儿童权利中心的定期访问。在第20周，将进行几项测试，这些测试将在第20-24周进行评估。在第20周出现病毒学反应的患者将在第48周接受治疗，并在第72周进行随访。 ，

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 cirhossis 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. ,