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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00684268
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : March 27, 2017
Information provided by (Responsible Party):
Peter Ferenci, Medical University of Vienna

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).

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Silibinin Phase 2

Detailed Description:
Since the publication of the first data the optimal dosing schedule is investigated

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2007
Actual Primary Completion Date : February 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: on treatment nonresponders
naive patients with null response to peginterferon/ribavirin at week 12 or partial response at week 24
Drug: Silibinin
20 mg/kg Silibinin iv /d /21 days, antiviral combination therapy will be continued

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

Primary Outcome Measures :
  1. viral response at week 24 [ Time Frame: week 24 ]

Secondary Outcome Measures :
  1. sustained virologic response [ Time Frame: week 72 ]
  2. Safety [ Time Frame: week 72 ]
    start to end of treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00684268

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Medical University of Vienna
Wien, Austria, A1090
Sponsors and Collaborators
Medical University of Vienna
Publications of Results:
Other Publications:
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Responsible Party: Peter Ferenci, Prof. of Medicine, Medical University of Vienna Identifier: NCT00684268    
Other Study ID Numbers: NRSili
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Keywords provided by Peter Ferenci, Medical University of Vienna:
chronic hepatitis C
efficacy of iv. silibinin
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Protective Agents
Physiological Effects of Drugs