About SyNCHOver 50% of patients with chronic hepatitis C infection (HCV) are either ineligible or do not achieve sustained virologic response with interferon-based therapies. And currently, there are no proven treatments for patients with non-alcoholic steatohepatitis (NASH). Therefore, both of these patient populations may benefit from the use of alternative medicines. Silybum marianum, or silymarin (common name: milk thistle), is used by 30-40% of patients with chronic liver diseases because of purported beneficial effects that include anti-inflammatory, anti-oxidant, and anti-fibrogenic activities. The lack of efficacy in several clinical trials using customary doses of silymarin suggests the need to evaluate higher doses. However, safe dose escalation is uncertain since the disposition of silymarin in patients with chronic liver disease is not known and may differ according to disease etiology or disease severity. Furthermore, the relative contributions of the six principal components (isomers) of silymarin to its safety and efficacy profile have not been previously investigated in a clinical trial.
This randomized, multicenter, double-blind, placebo-controlled Phase I investigation will evaluate the safety and pharmacokinetics of silymarin (Legalon® 140 mg capsules of milk thistle extract containing 77.5% silymarin) in subjects with HCV who have failed to respond to previous interferon-based therapies, and in subjects with non-alcoholic fatty liver disease (NAFLD). This study is being sponsored through a cooperative agreement U01 award from the NCCAM and the NIDDK (RFA-AT-05-006; “Phase I/II Trials of Silymarin for Chronic Liver Diseases”.