Chronic hepatitis C MedDRA version: 9.1 Level: LLT Classification code 10008912
Conditions
Interventions
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: E
Sponsors
AZIENDA OSPEDALIERA POLICLINICO DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Decompensated cirrhosis Prior treatment with standard or pegylated Interferon monotherapy or in combination with ribavirin hemoglobin concentration of less than 12 g per deciliter in women and less than 13 g per deciliter in men Patients with ALT (SGPT) levels > 10 x ULN. White-cell count less than 3000 per cubic millimeter Neutrophil count less than 1500 per cubic millimeter Platelet count less than 90,000 per cubic millimeter TSH alterations HIV infection HBV infection HCC or focal hepatic lesions at the ultrasound examination in the 3 months before alcohol abuse (more than 25 grams per day) Prior organ transplantation Severe psychiatric conditions Seizure disorder Cardiovascular disease Patients with serum creatinine > ULN or with significant proteinuria as indicated by a urinary protein/creatinine ratio ≥ 1.0 in a non-first void urine sample at baseline. Hemoglobinopathy Hemophilia Poorly controlled diabetes mellitus Immunologically mediated diseases Patients with considerable impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral deferasirox / ICL670 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). History of clinically relevant ocular or ear disorders. Patients with psychiatric or addictive disorders which prevent them from giving their informed consent or undergoing any of the treatment options or patients unwilling or unable to comply with the protocol Patients with a known history of HIV seropositivity (Elisa or Western blot). History of malignancy of any organ system, treated or untreated, within the past 5 years whether there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Pregnant or nursing (lactating) women are not eligible to participate in the study. Patients participating in another clinical trial or receiving an investigational drug. History of non-compliance with medical regimens or patients who are considered potentially unreliable and/or not cooperative, unwilling or unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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).;Primary end point(s): Assess the safety, tolerability and antiviral effect of iron chelation therapy with the oral chelator Deferasirox | — |
Countries
Italy
Outcome results
None listed