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Not Recruiting
Trial ID: NCT00938860
A Multi-center, Randomized, Open Label, Controlled Study to Compare the Sustained Virological Response During Treatment With Neoral or Tacrolimus in Maintenance Liver Transplant Recipients Treated With Pegylated Interferon and Ribavirin for Recurrent Hepatitis C
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
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
drug: cyclosporin (Neoral)
drug: tacrolimus (Prograf)
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mindie Nguyen, MD
650-498-7878