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

Hepatitis C Clinical Trial

— NRSily  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684268
• Other study ID #: NRSili
• Status: Completed
• Phase: Phase 2
• First received: May 19, 2008
• Last updated: March 22, 2017
• Start date: October 2007
• Est. completion date: June 2011

Study information

• Verified date: March 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Since the publication of the first data the optimal dosing schedule is investigated

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Silibinin
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
20 mg/kg Silibinin iv /d /21 days, antiviral combination therapy will be continued

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Wien

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (4)

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. — View Citation

Ferenci P, Scherzer TM, Kerschner H, Rutter K, Beinhardt S, Hofer H, Schöniger-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. Gast — View Citation

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. do — View Citation

Rutter K, Scherzer TM, Beinhardt S, Kerschner H, Stättermayer 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. Antiv — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	viral response at week 24		week 24
Secondary	sustained virologic response		week 72
Secondary	Safety	start to end of treatment	week 72