Hepatitis C
Conditions
Keywords
silibinin, chronic hepatitis C, peginterferon, ribavirin, nonresponders, efficacy of iv. silibinin, safety
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
Interventions
DRUGSilibinin
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
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| viral response at week 24 | week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sustained virologic response | week 72 | — |
| Safety | week 72 | start to end of treatment |
Countries
Austria
Outcome results
None listed