CLINICAL TRIAL: SILYMARIN (LEGALON?) IN NON-CIRRHOTIC SUBJECTS WITH CHRONIC HEP

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。 目的：这项多中心研究的目的是了解利加隆水飞蓟素在体内的分布情况，食物对水飞蓟素吸收的影响，以及不同剂量水飞蓟素在不同严重肝病患者中的安全性。我们还试图确定是否 患者从体内清除水飞蓟素的方式存在遗传差异。 参与者：之前干扰素治疗无效的慢性丙型肝炎病毒(丙型肝炎)患者和非酒精性脂肪性肝病(NAFLD)患者将纳入本研究。 程序(方法)：7个剂量组，每组8名受试者，共56名非肝硬化性肝病受试者将在四个地点入选。在单剂量和多剂量水飞蓟素后，将评估每个群体的药代动力学。由于这是一项剂量递增研究，药代动力学分析将在进入下一剂量水平之前进行。丙型肝炎病毒阳性受试者将在140、280(两个研究组)、560和700毫克剂量水平(第1、2、3、5、7组)进行研究。NAFLD受试者将接受280和560毫克剂量水平的评估(第4、6组)。

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. Purpose: The purpose of this multicenter research study is to learn about how Legalon¿, silymarin, is distributed throughout the body, the effect of food on the absorption of silymarin, and the safety of different silymarin doses in patients with varying severity of liver disease. We are also trying to identify if patients have genetic differences in the way they eliminate silymarin from the body. Participants: Subjects with chronic hepatitis C virus (HCV) who have failed to respond to previous interferon-based therapies, and subjects with non-alcoholic fatty liver disease (NAFLD) will be enrolled in this study. Procedures (methods): Seven dose groups with 8 subjects per group for a total of fifty-six (56) subjects with non-cirrhotic liver disease will be enrolled at four sites. The pharmacokinetics for each population will be evaluated after single and multiple doses of silymarin. Since this is a dose escalation study, the pharmacokinetic analysis will take place before entering into the next level of dosing. HCV-positive subjects will be studied at 140, 280 (2 study groups), 560 and 700 mg dose levels (Groups 1, 2, 3, 5, 7). Subjects with NAFLD will be evaluated at 280 and 560 mg dose levels (Groups 4, 6).