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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: March 22, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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:


Further study details as provided by Peter Ferenci, Medical University of Vienna:

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

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


Enrollment: 70
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 22, 2017

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

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

ClinicalTrials.gov processed this record on June 22, 2017