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

临床试验：水飞蓟素（LEGALON？）用于患有慢性 HEP 的非肝硬化患者

• 批准号: 7716889
• 负责人: ROY L HAWKE
• 金额: $ 2.01万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-02 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716889
• 关键词: Chronic; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Enrollment; Food; Funding; Genetic; Grant; Hepatitis C virus; Institution; Interferons; Learning; Legalon; Liver diseases; Methods; Participant; Patients; Population; Procedures; Purpose; Research; Research Personnel; Resources; Safety; Severities; Silymarin; Site; Source; United States National Institutes of Health; absorption; base; non-alcoholic fatty liver; research study

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).

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以出现在其他 CRISP 条目中 列出的机构是。 对于中心来说，它不一定是研究者的机构。 目的：这项多中心研究的目的是了解 Legalon 如何水飞蓟素分布于全身，食物对水飞蓟素吸收的影响，以及不同严重程度的肝病患者服用不同剂量的水飞蓟素的安全性，我们也在尝试确定。 患者从体内消除水飞蓟素的方式存在遗传差异。 参与者：对先前的基于干扰素的疗法没有反应的慢性丙型肝炎病毒（HCV）受试者，以及患有非酒精性脂肪肝病（NAFLD）的受试者将参加本研究。 程序（方法）：将在四个地点招募七个剂量组，每组 8 名受试者，总共五十六（56）名患有非肝硬化肝病的受试者，将在单次和多次剂量后评估每个群体的药代动力学。由于这是一项剂量递增研究，因此将在进入下一剂量水平的 HCV 阳性受试者之前进行药代动力学分析（2 项研究）。患有 NAFLD 的受试者将以 280 和 560 mg 剂量水平进行评估（第 4 组、第 6 组）。