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Completed

NCT Number: NCT00684268

Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders

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).

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of Vienna

Vienna, A1090, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silibinin

Drug

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

Primary outcomes

  1. viral response at week 24

    Time frame: week 24

Secondary outcomes

  1. sustained virologic response

    Time frame: week 72

  2. Safety

    Time frame: week 72

    start to end of treatment

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Acronym: NRSily

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 26, 2008
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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