Clinical Center for Phase I/II trials of Silymarin in Chronic Liver Disease

水飞蓟素治疗慢性肝病I/II期试验临床中心

• 批准号: 7123590
• 负责人: Nezam Hassan Afdahl
• 金额: $ 17.39万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-15 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7123590
• 关键词: clinical research; clinical trials; fibrosis; liver; placebos; quality of life

DESCRIPTION (provided by applicant): Complimentary and alternative medicines (CAM) are amongst the most commonly used therapies worldwide and in the US for chronic liver diseases. Silymarin, the active ingredient of the milk thistle, Silybum marianum, is one of the commonest used herbal medications but its efficacy in chronic liver disease is unproven. Liver disease secondary to both hepatitis C (HCV) and non-alcoholic steatohepatitis (NASH) represent 2 of the commonest liver diseases in the US and there is a need for the study of silymarin in these diseases in a controlled clinical trial. We are proposing three collaborative clinical trials to evaluate silymarin versus placebo in HCV patients who have never received treatment, in HCV patients who have failed treatment and in patients with NASH. These will be double blind, placebo controlled phase l/ll trials focusing on dose finding, safety and efficacy of silymarin. The endpoints of the trials will include histological improvement in liver disease and multiple secondary surrogate markers to understand both how silymarin works and to get a preliminary idea of the endpoints to be utilized in larger Phase 3 trials. We also intend to evaluate important secondary factors such as expectations of patients on CAM and effect of silymarin on quality of life. The goal of these studies is to determine whether there is a rationale for larger Phase 3 studies of silymarin in patients with chronic liver disease.

描述（由申请人提供）：免费和替代药物（CAM）是全球和美国最常用的慢性肝病治疗方法之一。水飞蓟素是水飞蓟的活性成分，是最常用的草药之一，但其对慢性肝病的疗效尚未得到证实。继发于丙型肝炎（HCV）和非酒精性脂肪性肝炎（NASH）的肝脏疾病是美国最常见的两种肝脏疾病，需要在对照临床试验中研究水飞蓟素在这些疾病中的作用。我们提出了三项合作临床试验，以评估水飞蓟素与安慰剂在从未接受过治疗的HCV患者，治疗失败的HCV患者和NASH患者中的作用。这些将是双盲、安慰剂对照的I/II期试验，重点是水飞蓟素的剂量发现、安全性和功效。这些试验的终点将包括肝脏疾病的组织学改善和多种次要替代标志物，以了解水飞蓟素的作用机制，并初步了解在大型3期试验中使用的终点。我们还打算评估重要的次要因素，如患者对CAM的期望和水飞蓟素对生活质量的影响。这些研究的目的是确定是否有理由在慢性肝病患者中进行更大规模的3期水飞蓟素研究。