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

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ClinicalTrials.gov Identifier: NCT00684268
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Ferenci, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE May 19, 2008
First Posted Date  ICMJE May 26, 2008
Last Update Posted Date March 27, 2017
Study Start Date  ICMJE October 2007
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2008)
viral response at week 24 [ Time Frame: week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • sustained virologic response [ Time Frame: week 72 ]
  • Safety [ Time Frame: week 72 ]
    start to end of treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2008)
sustained virologic response [ Time Frame: week 72 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • 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

    Other Name: 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
  • Drug: Silibinin
    20 mg/kg Silibinin iv /d /21 days, antiviral combination therapy will be continued
Study Arms  ICMJE
  • Experimental: on treatment nonresponders
    naive patients with null response to peginterferon/ribavirin at week 12 or partial response at week 24
    Intervention: Drug: Silibinin
  • Experimental: Nonresponders to previous antiviral combination therapy
    Nonresponders defined by viral status at weeks 4,12, and 24 of previous peginterferon/ribavirin combination therapy
    Intervention: Drug: Silibinin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2017)
70
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2008)
100
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00684268
Other Study ID Numbers  ICMJE NRSili
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Ferenci, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP