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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Ferenci, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00684268
First received: May 19, 2008
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Hepatitis C
 Drug: Silibinin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • viral response at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sustained virologic response [ Time Frame: week 72 ] [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
    start to end of treatment


Estimated Enrollment: 100
Study Start Date: October 2007
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684268

Locations
Austria
Medical University of Vienna
Wien, Austria, A1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

Publications:

Responsible Party: Peter Ferenci, Prof. of Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00684268     History of Changes
Other Study ID Numbers: NRSili
Study First Received: May 19, 2008
Last Updated: October 24, 2012
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:
silibinin
chronic hepatitis C
peginterferon
ribavirin
 nonresponders
efficacy of iv. silibinin
safety

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
 Interferons
Ribavirin
Peginterferon alfa-2a
Silybin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013