Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders
- Registration Number
- NCT00684268
- Lead Sponsor
- Medical University of Vienna
- Brief 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).
- Detailed Description
Since the publication of the first data the optimal dosing schedule is investigated
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description on treatment nonresponders Silibinin naive patients with null response to peginterferon/ribavirin at week 12 or partial response at week 24 Nonresponders to previous antiviral combination therapy Silibinin Nonresponders defined by viral status at weeks 4,12, and 24 of previous peginterferon/ribavirin combination therapy
- Primary Outcome Measures
Name Time Method viral response at week 24 week 24
- Secondary Outcome Measures
Name Time Method sustained virologic response week 72 Safety week 72 start to end of treatment
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Wien, Austria