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

A Randomized, Single Center, Comparative Study to Evaluate the Efficacy and Safety of Silibinin (Legalon® SIL) in Combination With Ribavirin or With Peginterferon and Ribavirin, Versus Peginterferon and Ribavirin Based Standard of Care (SoC) in Treatment of naïve Genotype 4 Patients With Chronic Hepatitis C

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.

Inclusion Criteria:

• Patient must be willing to give written informed consent
• Male and female patients; age between 21 and 45 years inclusive
• Chronic hepatitis C infection with genotype 4 confirmed by genotypic testing at screening or within 6 months of screening period
• Patients eligible to be treated with RBV and Peg-IFN as per the instructions present in their prescribing information documents
• No history of prior interferon therapy (treatment naïve)
• Detectable HCV-RNA levels
• Normal BUN and creatinine
• Ability to communicate, participate, and comply with the requirements of the entire study

Exclusion Criteria:

• Liver transplant patients

• Co-Infection with HIV and/or HBV

• ALT >10-fold the upper limit of normal i.e. > 400 U/L

• Evidence of hepatocellular carcinoma (HCC)

• Fibroscan® at screening with a score ≥ 14.5 kPa

• Evidence of liver disease due to causes other than chronic HCV infection

• Evidence of poorly controlled diabetes (defined as HbA1c > 8%)

• History of alcohol or drug abuse within the last 12 months

• History or clinical evidence of liver decompensation, e.g. presence of ascites or encephalopathy, or bleeding from esophageal varices

• Serum albumin levels < 3.2 g/dL

• INR > 1.3 N

• Total Bilirubin levels > 2.0 mg/dL unless explained by Gilbert's disease

• Platelet Count < 100,000 µL

• Absolute Neutrophil counts < 1500 µL (mm3)

• Active or suspected non-hepatic malignancy or history of malignancy within the last 5 years

• Body Mass Index < 16 or > 35 kg/m2

• Females of childbearing potential:

  • Pregnancy (i.e. positive urine pregnancy test at screening) or lactation
  • Failure to agree to practice adequate contraception methods (e.g. oral contraceptives, intra-uterine device (IUD), transdermal contraceptive patch)

• Male patients not vasectomized, who do not agree to abstain from intercourse or who do not use a condom