Trial Information

Summary: Phase I Single and Multiple Dose Escalation of Milk Thistle to Evaluate the Safety, Tolerability, and Pharmacokinetics in subjects with Hepatitis C who have previously been treated with interferon and subjects with Nonalcoholic Fatty liver Disease.

This study, sponsored by the National Institutes of Health will evaluate the safety, tolerability and pharmacokinetics of silymarin (milk thistle) in patients with chronic hepatitis C infection (HCV) who do not achieve sustained virologic response with interferon-based therapies and in patients with non alcoholic fatty liver disease. 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 liver protecting activities.

Patient Inclusion Criteria

• Males or females; age at least 18 years at screening
• Abnormal ALT level
• Hepatitis C virus (HCV) patients
• Previous treatment with any interferon-based therapy without sustained virological response
• Serum HCV RNA above quantifiable level of detection by the assay, within 1 year of screening and after end of therapy
• No antiviral therapy for at least 6 months prior to screening visit

Nonalcoholic fatty liver disease (NAFLD) patients:

• Liver biopsy compatible with NAFLD within 3 years of screening
• Absence of other liver diseases by serological screening (anti-HCV, HBsAg), historical serological data from within 3 years of screening is acceptable

Patient Exclusion Criteria

• Use of silymarin or other milk thistle preparations within 30 days of screening
• Use of other antioxidants such as vitamin E, vitamin C, glutathione, alpha-tocopherol, within 30 days of screening. A multivitamin at standard doses will be allowed.
• Allergy/sensitivity to milk thistle or its preparations
• Use of silymarin or other antioxidants (as above) during the screening period
• Use of warfarin, metronidazole or chronic use of acetaminophen greater than two gram per day
• Previous liver biopsy that demonstrated presence of cirrhosis

If you would like to learn more about participating in this study, please send an e-mail message using the form below.