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

基本信息

批准号：
8128340
负责人：
Nezam Hassan Afdahl
金额：
$ 10.36万
依托单位：
BETH ISRAEL DEACONESS MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-08-15 至 2011-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8128340
关键词：
Affect Alternative Medicine American Antioxidants Body Weight decreased Chronic Chronic Hepatitis Cirrhosis Clinical Clinical Research Clinical Trials Complementary and alternative medicine Controlled Clinical Trials Development Diabetes Mellitus Disease Disease Progression Dose Double-Blind Method Exercise Fibrosis Future Genotype Goals Hepatitis C Hepatitis C virus Hepatoprotective Agent Histologic Inflammation Institutes Interferons Lead Liver diseases Malignant neoplasm of liver Metabolic syndrome Methodology Milk Thistle Multi-Institutional Clinical Trial Obesity Oxidative Stress Patients Persons Pharmaceutical Preparations Phase Phase I/II Trial Phase III Clinical Trials Placebo Control Placebo Effect Placebos Population Population Characteristics Preparation Quality of life Research Design Research Personnel Ribavirin ST14 gene Safety Secondary to Serological Silymarin Site Staging Surrogate Markers Therapeutic United States Variant Virus Work base clinical research site efficacy evaluation indexing inflammatory marker liver biopsy medical schools non-alcoholic fatty liver nonalcoholic steatohepatitis novel patient expectation patient population phase 3 study viral liver disease willingness

项目摘要

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）：全世界最常用的疗法和在美国的慢性肝病疗法是最常用的疗法之一。牛奶蓟的活性成分，玛丽安玛丽安（Sillbum Marianum）是最常见的草药药物之一，但其在慢性肝病中的功效尚未得到证实。继发于丙型肝炎（HCV）和非酒精性脂肪性肝炎（NASH）继发的肝病代表了美国最常见的肝脏疾病中的2种，并且需要在一项受控临床试验中研究这些疾病中的甲硅烷基素。我们正在提出三项协作临床试验，以评估从未接受过治疗的HCV患者的HCV患者中的水莲蛋白与安慰剂，该患者在治疗失败和NASH患者的HCV患者中。这些将是双盲，安慰剂对照期L/LL试验，重点是剂量发现，安全性和效果。试验的终点将包括肝病和多个次级替代标记的组织学改善，以了解水莲蛋白的工作原理，并在较大的3阶段试验中使用终点的初步概念。我们还打算评估重要的次要因素，例如对患者对CAM的期望以及面包莲素对生活质量的影响。这些研究的目的是确定在慢性肝病患者中，是否有针对水莲蛋白的大型阶段研究的理由。