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

March 22, 2017 updated by: Peter Ferenci, Medical University of Vienna

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, A1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

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 Names:
  • 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
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
viral response at week 24
Time Frame: week 24
week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sustained virologic response
Time Frame: week 72
week 72
Safety
Time Frame: week 72
start to end of treatment
week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 21, 2008

First Posted (Estimate)

May 26, 2008

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRSili

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe