Multicenter Study To Evaluate The Efficacy Of Silymarin In Addition To Combination-Therapy With Pegylated Interferon Alfa 2a (Peg-Ifn Alfa 2a) And Ribavirin In Patients With Chronic Hepatitis C
| Registry | NCT00684268, acronym NRSily |
|---|
| Status | Completed |
|---|
| Phase | Phase 2 |
|---|
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
|---|
| Enrollment | 70 (Actual) |
|---|
| Sponsor | Medical University of Vienna (Other) |
|---|
| Conditions | Hepatitis C |
|---|
| Interventions | Silibinin (Drug) |
|---|
| Dates | start 2007-10-01, primary completion 2011-02-01, completion 2011-06-01, first posted 2008-05-26, last updated 2017-03-27 |
|---|
| Locations | 1 site in Austria |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Hepatitis C All trials of Silibinin
-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).
Expand all sections · Collapse all
+Detailed description
Since the publication of the first data the optimal dosing schedule is investigated
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| on treatment nonresponders | Experimental | Drug: Silibinin | naive patients with null response to peginterferon/ribavirin at week 12 or partial response at week 24 |
| Nonresponders to previous antiviral combination therapy | Experimental | Drug: Silibinin | Nonresponders defined by viral status at weeks 4,12, and 24 of previous peginterferon/ribavirin combination therapy |
- Silibinin (Drug), also known as Silibinin infusions (20 mg/kg/d infused over 2 hours)given for 21 (either Monday -Friday or daily) or 28 days, continuation of antiviral combination therapy: 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
- Silibinin (Drug): 20 mg/kg Silibinin iv /d /21 days, antiviral combination therapy will be continued
+Outcome measures
Primary outcomes
- viral response at week 24 [week 24]
Secondary outcomes
- sustained virologic response [week 72]
- Safety [week 72]: start to end of treatment
+Eligibility
Sex: All, ages: 19 Years to 70 Years
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
+Locations (1)
| Facility | City | Country | Status |
|---|
| Medical University of Vienna | Vienna | Austria | |
+Publications
- Beinhardt S, Rasoul-Rockenschaub S, Scherzer TM, Ferenci P. Silibinin monotherapy prevents graft infection after orthotopic liver transplantation in a patient with chronic hepatitis C. J Hepatol. 2011 Mar;54(3):591-2; author reply 592-3. doi: 10.1016/j.jhep.2010.09.009. Epub 2010 Oct 14. No abstract available. PMID 21106270
- Results publication: Ferenci P, Scherzer TM, Kerschner H, Rutter K, Beinhardt S, Hofer H, Schoniger-Hekele M, Holzmann H, Steindl-Munda P. Silibinin is a potent antiviral agent in patients with chronic hepatitis C not responding to pegylated interferon/ribavirin therapy. Gastroenterology. 2008 Nov;135(5):1561-7. doi: 10.1053/j.gastro.2008.07.072. Epub 2008 Aug 3. PMID 18771667
- Results publication: Payer BA, Reiberger T, Rutter K, Beinhardt S, Staettermayer AF, Peck-Radosavljevic M, Ferenci P. Successful HCV eradication and inhibition of HIV replication by intravenous silibinin in an HIV-HCV coinfected patient. J Clin Virol. 2010 Oct;49(2):131-3. doi: 10.1016/j.jcv.2010.07.006. Epub 2010 Aug 14. PMID 20709593
- Results publication: Rutter K, Scherzer TM, Beinhardt S, Kerschner H, Stattermayer AF, Hofer H, Popow-Kraupp T, Steindl-Munda P, Ferenci P. Intravenous silibinin as 'rescue treatment' for on-treatment non-responders to pegylated interferon/ribavirin combination therapy. Antivir Ther. 2011;16(8):1327-33. doi: 10.3851/IMP1942. PMID 22155914