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

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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).