Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT00938860
Eligibility Criteria:
Inclusion criteria:
* 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.
Exclusion criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00938860
Study Brief:
Protocol Section:
NCT00938860