Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

By chance the investigators found that iv. silibinin has a potent antiviral effect against the hepatitis C virus. Based on the results of the dose finding study (published) te optima dosing schedule is explored.This study will be evaluate whether the highest active dose given for the optimal time combined with standard of care will result in a sustained virologic response (=cure of hepatitis C).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Antiviral Agents; Interferons; Peginterferon alfa-2a; Ribavirin; Silybin; Silymarin

Criteria

Inclusion Criteria:

• Nonresponders to full dose PEG-IFN/RBV therapy

• Liver biopsy within the last 2 year

Exclusion Criteria:

• Intolerance to one of the study drugs

• Coinfection with HIV/HBV