QUANTITATIVE ASSESSMENT OF HEPATIC FUNCTION IN CHRONIC HEPATITIS C

慢性丙型肝炎肝功能的定量评估

• 批准号: 7604993
• 负责人: Mitchell L Shiffman
• 金额: $ 4.85万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-20 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604993
• 关键词: Abdomen; Ancillary Study; Antiviral Therapy; Ascites; Blood; Blood Circulation; Brain; Caffeine; Catheters; Cessation of life; Chronic Hepatitis; Chronic Hepatitis C; Cirrhosis; Clinical; Computer Retrieval of Information on Scientific Projects Database; Degenerative Disorder; Diet; Disease Progression; Eating; Encephalopathies; End Point; Evaluation; Fibrosis; Funding; Grant; Hemorrhage; Hepatic; Hepatitis C; Hepatitis C virus; Histologic; Home environment; Hour; Institution; Interferons; Intravenous; Liquid substance; Liver; Liver Function Tests; Liver diseases; Maintenance; Maintenance Therapy; Malignant neoplasm of liver; Measurement; Measures; Patients; Pharmaceutical Preparations; Prevention; Research; Research Personnel; Resources; Ribavirin; Risk; Saliva; Sampling; Scanning; Score; Source; Staging; Standards of Weights and Measures; Testing; Time; United States National Institutes of Health; Upper arm; Veins; day; liver function; liver transplantation; response; single photon emission computed tomography

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. An evaluation of the usefulness of certain tests of the liver function and liver blood circulation; an ancillary study to the HALT-C trial. It is estimated that 8,000 to 10,000 patients in the U.S. died in 1998 and 30,000 will die annually by the year 2010, as a direct result of advanced liver disease from chronic hepatitis C (HCV). Patients with advanced histologic stages of hepatitis C, bridging fibrosis and cirrhosis, are at greatest risk of developing clinical evidence of hepatic decompensation, need for liver transplantation, liver cancer, and death from liver disease. The hypothesis for the National Institutes of Health Trial of HCV nonresponders wth fibrosis or cirrhosis is that long-term use of antiviral therapy (maintenance treatment) will slow the progression of liver disease. In noncirrhotic patients who have significant fibrosis, effective maintenance therapy is expected to slow or stop histologic progression to cirrhosis. Standard endpoints for effective response to maintenance therapy in cirrhotic patients are prevention of clinical decompensation, (ascites [the accumulation of fluid in the abdomen], variceal hemorrhage[bleeding from enlarged veins], encephalopathy [degenerative diseases of the brain]), and stabilization of liver function as measured clinically by Childs-Turcott-Pugh (CTP) score. However, clinical endpoints are insensitive parameters of disease progression. HALT-C treatment is long-term therapy with interferon plus ribavirin. Testing will be done three times during this study. First, at baseline, before the beginning of the HALT-C medications, and two and four years after the first six months of treatment. Each testing period will be the same. Patients will be admitted to the CRC for one day. Diets will be caffeine free three days before and three days after the tests and there will be a pre-admit overnight fast. Saliva samples will be collected at home twice a day for two days after testing and then brought to the CRC. At the time of testing , there will be an intravenous catheter placed into the arm to draw blood and administer test compounds. Six saliva samples will be collected over three days. Three compounds will be given by vein and three will be given orally. Blood will be drawn to see how the liver clears these compounds. After the tests are complete, the patient will eat a normal meal. Two hours later a SPECT Scan will be done to allow measurement of hepatic function.

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。 对肝功能和肝脏血液循环某些测试的有用性的评估；HALT-C试验的辅助研究。 据估计，1998年美国有8000至10000名患者死亡，到2010年每年将有3万人死亡，直接原因是慢性丙型肝炎(丙型肝炎)引发的晚期肝病。丙型肝炎的晚期组织学阶段患者，桥接纤维化和肝硬变，最有可能出现肝脏失代偿、需要肝移植、肝癌和死于肝病的临床证据。 美国国立卫生研究院对肝纤维化或肝硬变的丙型肝炎病毒无反应者进行试验的假设是，长期使用抗病毒治疗(维持治疗)将减缓肝病的进展。对于有显著纤维化的非肝硬变患者，有效的维持治疗有望减缓或阻止组织学进展为肝硬变。肝硬变患者对维持治疗的有效反应的标准终点是预防临床失代偿(腹水[腹水积聚]、静脉曲张出血[扩大静脉出血]、脑病[脑退行性疾病])，以及临床上用Childs-Turcott-Pugh(CTP)评分衡量的肝功能稳定。然而，临床终点是疾病进展的不敏感参数。 HALT-C治疗是干扰素加利巴韦林的长期治疗。在这项研究期间，将进行三次测试。首先，在基线，在HALT-C药物开始之前，以及治疗前六个月后的两年和四年。每个测试期都是一样的。患者将被送往儿童权利中心一天。测试前三天和测试后三天的饮食将不含咖啡因，并将提前承认隔夜禁食。唾液样本将在检测后的两天内每天在家中采集两次，然后带到儿童权利中心。 在测试时，将有一个静脉导管放置在手臂上，以抽血和给药测试化合物。将在三天内采集六个唾液样本。三种化合物将通过静脉给药，三种将被口服。取血看看肝脏是如何清除这些化合物的。 在检查完成后，患者将吃一顿正常的饭。两小时后，将进行SPECT扫描，以测量肝功能。