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).
Since the publication of the first data the optimal dosing schedule is investigated
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
comparison of different dosing schedule of Silibinin infusions (20 mg/kg/d infused over 2 hours) A: 3x5days B: 14 days C: 21 days D: 28 days sequential the infusion duration will be shortened - 2 hours, then 1 hr and then 1/2 hr/infusion
20 mg/kg Silibinin iv /d /21 days, antiviral combination therapy will be continued
Medical University of Vienna
Vienna, Austria
viral response at week 24
Time frame: week 24
sustained virologic response
Time frame: week 72
Safety
start to end of treatment
Time frame: week 72
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