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

临床试验：HEP C 抗病毒药物长期治疗肝硬化 (HALT-C)

• 批准号: 7717009
• 负责人: Mitchell L Shiffman
• 金额: $ 21.35万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717009
• 关键词: Adult; Affect; Alcohol consumption; Antiviral Agents; Antiviral Therapy; Blood Tests; Cessation of life; Chronic Hepatitis C; Cirrhosis; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Consent Forms; Daily; Development; Dose; Drug usage; Effectiveness; Fatigue; Fibrosis; Funding; Grant; Hepatic; Hepatitis C; Hepatitis C virus; Institution; Interferons; Liver; Malignant neoplasm of liver; Patients; Physical Examination; Predisposing Factor; Primary carcinoma of the liver cells; Psyche structure; Quality of life; Questionnaires; Recording of previous events; Research; Research Personnel; Resources; Ribavirin; Risk; Screening procedure; Secondary to; Source; Testing; Transplantation; Ultrasonography; United States; United States National Institutes of Health; Urinalysis; Visit; Week; Weight; follow-up; improved; interferon therapy; liver biopsy; liver transplantation; peginterferon alfa-2a; prevent; response; treatment program

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 cirhosis 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. ,

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。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。列出的机构是 对于中心，这不一定是调查员的机构。 确定长期抗病毒治疗对慢性丙型肝炎（HALT-C）的有效性，其长期peginterferon alfa-2a在未能对先前的干扰素治疗反应的患者中的有效性。 由丙型肝炎病毒（HCV）引起的慢性丙型肝炎会影响美国的400万患者，每年导致10,000例死亡。丙型肝炎是肝移植的最常见原因，是美国肝癌发展的主要因素。此外，丙型肝炎也会在12％的患者和其他各种非肝脏问题中产生衰弱的疲劳。 这项研究将尝试确定干扰素长期治疗是否可以安全地防止晚期纤维化向肝炎的进展，而丙型肝炎患者未能对以前的干扰素治疗反应。它将确定是否降低了发育肝功能补偿的风险和发展肝细胞癌的风险。 在这四年的治疗计划中，具体的目的是减少发展肝功能消耗的风险，减少移植需求并降低患肝癌的风险。另外，还将确定三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。 这项研究将包括165名对干扰素过程的未响应记录的成年人。在筛查期间，将进行历史，身体检查和血液检查。将提供有关吸毒，饮酒和精神状态的问卷。第一次通过第一次的患者进行了第二次筛查，包括完成问卷，同意书的签名，尿液分析，肝活检和肝脏的超声检查。 至少八周后，将进行基线访问。所有患者将仅一次每周一次用Peginterferon alfa-2a治疗，或以两种剂量给予的利巴韦林。剂量根据重量处方。第2-20周，将定期进行CRC访问。在第20周，将进行几项测试，这些测试将在20-24周期间进行评估。 在第20周有病毒反应的患者将通过第48周进行治疗，并在第72周进行随访。 ，，，，