Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Liver transplantation performed at least 6 months and up to 5 years prior randomization and due to HCV cirrhosis, with or without pre-transplant hepatocellular carcinoma (HCC) within Milan or UCSF criteria
Immunosuppresive regimen based on tacrolimus b.i.d.- (twice or once daily) for at least 6 months prior randomization
Diagnosis of HCV genotypes 1 or 4 infection prior to transplantationconfirmed at screening
Indication of treatment with Peg-IFN and ribavirin due to histological evidence of chronic HCV infection defined as a fibrosis stage equal or greater than 1 using the Ishak-Knodell scoring system (IK ≥1) in a liver biopsy performed at screening or up to 4 months prior to randomization.
You may not be if
Serum creatinine \>150 μmol/L (1.6 7 mg/dL) or eGFR \< 50 ml/min (4-variable Modification of Diet in Renal Disease \[MDRD Cockcroft-Gault formula\])
Multi-organ transplant recipients
Recent episode of steroid-treated acute rejection (AR) within 3 months prior to randomization, or \>1 episode of steroid-treated AR in the last 6 months, or any number of steroid-resistant AR episodes in the last 6 months including evidence of chronic rejection or ductopenia
Evidence of conditions that could cause graft dysfunction other than HCV infection
Patients with signs of decompensated liver disease, defined as presence of ascites, variceal bleeding, encephalopathy or deteriorated hepatic synthetic function (albumin \<3.5g/dL or, total direct bilirubin \>1.5mg/dL or, INR \>1.5)
Co-infection with HIV or Hepatitis B (defined as HBsAg-positive) at screening
Use of mTOR inhibitors (everolimus or sirolimus) in the 6 months prior to screening
Antiviral treatment for HCV administered at any time after liver transplantation
Patients on daily doses of corticosteroids higher than 5 mg/day
Patients with fibrosing cholestatic hepatitis
Patients with current diagnosis of malignancies, including lymphoproliferative disorders
Patients with platelet count \<70,000/mm3 or neutrophiles \<1,500/mm3
History of HCC outside Milan criteria based on radiology or UCSF criteria based on analysis of the explant
