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Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders (NRSily)

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Silibinin
Silibinin
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring silibinin, chronic hepatitis C, peginterferon, ribavirin, nonresponders, efficacy of iv. silibinin, safety

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

on treatment nonresponders

Nonresponders to previous antiviral combination therapy

Arm Description

naive patients with null response to peginterferon/ribavirin at week 12 or partial response at week 24

Nonresponders defined by viral status at weeks 4,12, and 24 of previous peginterferon/ribavirin combination therapy

Outcomes

Primary Outcome Measures

viral response at week 24

Secondary Outcome Measures

sustained virologic response
Safety
start to end of treatment

Full Information

First Posted
May 19, 2008
Last Updated
March 22, 2017
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00684268
Brief Title
Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
silibinin, chronic hepatitis C, peginterferon, ribavirin, nonresponders, efficacy of iv. silibinin, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
on treatment nonresponders
Arm Type
Experimental
Arm Description
naive patients with null response to peginterferon/ribavirin at week 12 or partial response at week 24
Arm Title
Nonresponders to previous antiviral combination therapy
Arm Type
Experimental
Arm Description
Nonresponders defined by viral status at weeks 4,12, and 24 of previous peginterferon/ribavirin combination therapy
Intervention Type
Drug
Intervention Name(s)
Silibinin
Other Intervention Name(s)
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
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Silibinin
Intervention Description
20 mg/kg Silibinin iv /d /21 days, antiviral combination therapy will be continued
Primary Outcome Measure Information:
Title
viral response at week 24
Time Frame
week 24
Secondary Outcome Measure Information:
Title
sustained virologic response
Time Frame
week 72
Title
Safety
Description
start to end of treatment
Time Frame
week 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical University of Vienna
City
Wien
ZIP/Postal Code
A1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
21106270
Citation
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.
Results Reference
background
PubMed Identifier
18771667
Citation
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.
Results Reference
result
PubMed Identifier
20709593
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. doi: 10.1016/j.jcv.2010.07.006. Epub 2010 Aug 14.
Results Reference
result
PubMed Identifier
22155914
Citation
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.
Results Reference
result

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

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