drugset / Trial / NCT01871662

Randomized Study for the Assessment of Silibinin (Legalon® SIL) in the Treatment of naïve Genotype 4 Patients With Chronic Hepatitis C

NCT01871662

Phase 2/3 Withdrawn Rottapharm
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to explore whether silibinin plus ribavirin with/without peg-interferon can be more effective than the peg-interferon plus ribavirin based standard of care (SoC) in the treatment of patients infected with hepatitis C virus genotype 4.

Timeline

Start
2013-08
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Legalon® SIL Unknown 20 mg/kg
Subject Peginterferon alfa-2b Protein / enzyme biologic 1.5 ug/kg Subcutaneous
Background Ribavirin Small molecule 800 mg Oral
Background Ribavirin Small molecule 1400 mg Oral