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: 7375119
• 负责人: Mitchell L Shiffman
• 金额: $ 2.88万
• 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/7375119
• 关键词: QUANTITATIVE; ASSESSMENT; HEPATIC; FUNCTION; CHRONIC

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 with 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.

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。评价某些肝功能和肝脏血液循环检查的有用性; HALT-C试验的辅助研究。 据估计，1998年美国有8，000至10，000名患者死亡，到2010年每年将有30，000人死亡，这是慢性丙型肝炎（HCV）引起的晚期肝病的直接结果。丙型肝炎组织学晚期、桥接纤维化和肝硬化的患者发生肝失代偿、需要肝移植、肝癌和肝病死亡的临床证据的风险最大。 美国国立卫生研究院对患有纤维化或肝硬化的HCV无应答者进行的试验的假设是，长期使用抗病毒治疗（维持治疗）将减缓肝病的进展。在有显著纤维化的非肝硬化患者中，有效的维持治疗有望减缓或阻止组织学进展为肝硬化。维持治疗有效缓解的标准终点是预防临床失代偿（腹水[腹腔积液]、静脉曲张出血[扩大静脉出血]、脑病[脑退行性疾病]）和肝功能稳定（通过临床Childs-Turcott-Pugh（CTP）评分测量）。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。本研究期间将进行三次检测。首先，在基线时，在HALT-C药物开始之前，以及治疗前六个月后的两年和四年。每个测试周期都是相同的。患者将在CRC住院一天。饮食将是咖啡因免费三天前和三天后的测试，将有一个预先承认过夜快。唾液样本将在家中收集，每天两次，持续两天，然后带到CRC。 在试验时，将在手臂中放置静脉导管，以抽取血液并给予供试化合物。将在三天内收集六份唾液样本。三种化合物将通过静脉给药，三种将口服给药。将抽血观察肝脏如何清除这些化合物。检查完成后，患者将正常进食。两小时后，将进行SPECT扫描，以测量肝功能。