CLINICAL TRIAL: PHASE I STUDY OF SILYMARIN IN CHRONIC HEPATITIS C OR FATTY LIVER

临床试验：水飞蓟素治疗慢性丙型肝炎或脂肪肝的 I 期研究

• 批准号: 7718934
• 负责人: Nezam Hassan Afdahl
• 金额: $ 0.49万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718934
• 关键词: American; Biological Availability; Chronic Hepatitis; Chronic Hepatitis C; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cross-Over Studies; Daily; Dose; Double-Blind Method; Drug Kinetics; Fatty Liver; Funding; Grant; Hepatitis C virus; Institution; Isomerism; Legalon; Liver diseases; Oral; Patients; Phase; Phase I Clinical Trials; Placebo Control; Randomized; Relative (related person); Research; Research Personnel; Resources; Safety; Silymarin; Source; Time; United States National Institutes of Health; Upper arm; design; non-alcoholic fatty liver

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. This phase 1 study is designed to evaluate the safety, tolerability and pharmacokinetics of orally administered silymarin in non-cirrhotic subjects with chronic hepatitis C and non-alcoholic fatty liver disease. The primary objective is to identify silymarin exposure levels in patients with non-cirrhotic liver disease that are safe and to determine if exposures are dose-proportional, as well as to determine the pharmacokinetics for the six principal silymarin isomers, after single and multiple doses of Legalon administered orally up to 700 mg three times daily in patients with either HCV or NAFLD. The secondary objectives are to determine the effect of a typical 800 kcal American meal on the relative oral bioavailability of the six principal isomers of silymarin following a single Legalon dose of 280 mg in patients with HCV. This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-escalation study that includes a crossover study arm designed to evaluate the effect of a high calorie meal on the bioavailability of Legalon.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项1期研究旨在评估口服水飞蓟素在患有慢性丙型肝炎和非酒精性脂肪肝的非酒精性受试者中的安全性，耐受性和药代动力学。主要目的是确定在患有HCV或NAFLD的患者中，在口服高达700 mg每日三次的Legalon单次和多次剂量后，患有非酒精性肝病的患者中安全的水飞蓟素暴露水平，并确定暴露是否与剂量成比例，以及确定六种主要水飞蓟素异构体的药代动力学。 次要目的是确定HCV患者单次服用280 mg Legalon后，典型的800 kcal美国餐对水飞蓟素六种主要异构体的相对口服生物利用度的影响。 这是一项多中心、随机、双盲、安慰剂对照、平行组剂量递增研究，包括一个交叉研究组，旨在评价高热量膳食对Legalon生物利用度的影响。