NCT00684268

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

3.3 years

First QC Date

May 19, 2008

Last Update Submit

March 22, 2017

Conditions

Hepatitis C

Keywords

silibininchronic hepatitis Cpeginterferonribavirinnonrespondersefficacy of iv. silibininsafety

Outcome Measures

Primary Outcomes (1)

  • viral response at week 24

    week 24

Secondary Outcomes (2)

  • sustained virologic response

    week 72

  • Safety

    week 72

Study Arms (2)

on treatment nonresponders

EXPERIMENTAL

naive patients with null response to peginterferon/ribavirin at week 12 or partial response at week 24

Drug: Silibinin

Nonresponders to previous antiviral combination therapy

EXPERIMENTAL

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

Drug: Silibinin

Interventions

SilibininDRUG

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

Also known as: 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
Nonresponders to previous antiviral combination therapy

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nonresponders to full dose PEG-IFN/RBV therapy
  • Liver biopsy within the last 2 year

You may not qualify if:

  • Intolerance to one of the study drugs
  • Coinfection with HIV/HBV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, A1090, Austria

Location

Related Publications (4)

  • Beinhardt S, Rasoul-Rockenschaub S, Scherzer TM, Ferenci P. Silibinin monotherapy prevents graft infection after orthotopic liver transplantation in a patient with chronic hepatitis C. J Hepatol. 2011 Mar;54(3):591-2; author reply 592-3. doi: 10.1016/j.jhep.2010.09.009. Epub 2010 Oct 14. No abstract available.

    PMID: 21106270BACKGROUND

  • Ferenci P, Scherzer TM, Kerschner H, Rutter K, Beinhardt S, Hofer H, Schoniger-Hekele M, Holzmann H, Steindl-Munda P. Silibinin is a potent antiviral agent in patients with chronic hepatitis C not responding to pegylated interferon/ribavirin therapy. Gastroenterology. 2008 Nov;135(5):1561-7. doi: 10.1053/j.gastro.2008.07.072. Epub 2008 Aug 3.

    PMID: 18771667RESULT

  • Payer BA, Reiberger T, Rutter K, Beinhardt S, Staettermayer AF, Peck-Radosavljevic M, Ferenci P. Successful HCV eradication and inhibition of HIV replication by intravenous silibinin in an HIV-HCV coinfected patient. J Clin Virol. 2010 Oct;49(2):131-3. doi: 10.1016/j.jcv.2010.07.006. Epub 2010 Aug 14.

    PMID: 20709593RESULT

  • Rutter K, Scherzer TM, Beinhardt S, Kerschner H, Stattermayer AF, Hofer H, Popow-Kraupp T, Steindl-Munda P, Ferenci P. Intravenous silibinin as 'rescue treatment' for on-treatment non-responders to pegylated interferon/ribavirin combination therapy. Antivir Ther. 2011;16(8):1327-33. doi: 10.3851/IMP1942.

    PMID: 22155914RESULT

MeSH Terms

Conditions

Hepatitis CHepatitis C, Chronic

Interventions

Silybin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SilymarinFlavonolignansFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. of Medicine

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 26, 2008

Study Start

October 1, 2007

Primary Completion

February 1, 2011

Study Completion

June 1, 2011

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

AU(1)