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

NCT00684268 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-03-27

No results posted yet for this study

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).

Conditions

  • Hepatitis C

Interventions

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

DRUG

Silibinin

20 mg/kg Silibinin iv /d /21 days, antiviral combination therapy will be continued

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-02-28
Completion
2011-06-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00684268 on ClinicalTrials.gov