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

Medical University of Vienna

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Drug: Silibinin

Study type: Interventional

Funder types: Other

Identifiers

NCT00684268

NRSili

Details and patient eligibility

About

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).

Full description

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

Enrollment: 70 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

on treatment nonresponders

Experimental group

Description:

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

Treatment:

Drug: Silibinin

Drug: Silibinin

Nonresponders to previous antiviral combination therapy

Experimental group

Description:

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

Treatment:

Drug: Silibinin

Drug: Silibinin