Phase I/II Trials of Silymarin for Chronic Liver Diseases Data Coordinating Cente

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DESCRIPTION (provided by applicant): A consortium including 4 clinical sites, a data coordinating center, and project scientists and medical officers from the National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is being formed as a cooperative agreement to design and implement three phase l/ll trials of silymarin for patients with liver disease. Although silymarin has been used to treat liver disease for hundreds of years, there has not been rigorous research to indicate that such therapy is safe or efficacious. There is a potential role for silymarin, particularly for treating patients with chronic hepatitis C virus who have contraindications to therapy with interferon and ribavirin. The current lack of therapy for non-alcoholic steatohepatitis provides silymarin with a potential role in treating patients with this condition. Our proposed DCC will bring together expertise in biostatistics; pharmacodynamics and pharmacokinetics, particularly of silymarin; hepatology; epidemiology; data management; and computer systems to assist the consortium with designing and implementing multiple studies. Working in collaboration with the clinical sites and NIH scientists and personnel, the DCC will provide the consortium with assistance in: 1. Study design, implementation, and management of approximately three multi-center phase l/ll clinical trials. 2. Developing research databases containing information about approximately 480 participants recruited at 4 clinical sites to address safety and efficacy of silymarin for treating patients with liver disease. 3. Provide clinical, methodological, data management, and statistical expertise to design the studies, accurately computerize the data, monitor study operations and patient safety, analyze the data, and report the results. 4. Provide administrative support to the Steering Committee, subcommittees of the Steering Committee, NIH project scientists and medical officers, and Data and Safety Monitoring Board.