A randomized, open label, single center, phase IIa controlled trial to assess tolerability, safety and effect of treatment with deferasirox plus standard antiviral therapy versus standard antiviral therapy in chronic hepatitis C patients na�ve to treatment with interferon and/or ribavirin

INTERVENTION: Trade Name: EXJADE*28CPR DISP 125MG Pharmaceutical Form: Tablet INN or Proposed INN: Deferasirox Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125‐ Trade Name: EXJADE*28CPR DISP 250MG Pharmaceutical Form: Tablet INN or Proposed INN: Deferasirox Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250‐ Trade Name: EXJADE*28CPR DISP 500MG Pharmaceutical Form: Tablet INN or Proposed INN: Deferasirox Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ CONDITION: Chronic hepatitis C ; MedDRA version: 9.1 Level: LLT Classification code 10008912 PRIMARY OUTCOME: Main Objective: To assess the relative effect of adding 10 and 15 mg of deferasirox to antiviral treatment for hepatitis C (pegylated interferon and ribavirin) on safety in patients with chronic hepatitis C. Primary end point(s): Assess the safety, tolerability and antiviral effect of iron chelation therapy with the oral chelator Deferasirox Secondary Objective: ‐ To evaluate pharmacokinetic of deferasirox 10 and 15 mg/kg, ‐ To estimate Rapid (RVR) and Early (EVR) Virological Response rates as defined respectively by a 2 log drop or disappearance of HCV RNA at week 4 and 12 of treatment, in patients undergoing antiviral therapy with and without deferasirox. ‐ To estimate Sustained Virological Response (SVR) as defined by undetectable HCV RNA 6 months after end of antiviral treatment in patients undergoing antiviral therapy with and without deferasirox. ‐ Elastometric evaluation of liver stiffness by FIBROSCAN scores. It will be determined at baseline (Visit 1) and at Follow‐Up Visit (Visit 9). INCLUSION CRITERIA: Male or female patients with chronic hepatitis C, genotype 1, candidate to antiviral therapy, viral load ≥ 400,000 IU/ml of viral Hapatitis C RNA at the time of screening only and METAVIR score F0, F1, F2 or F3 Age ≥18 years. HCV‐RNA and HCV‐antibodies positivity Serum ferritin >100 ng/ml (male) or > 50 ng/ml (female) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range