Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C

Not Recruiting

Trial ID: NCT00938860


This study will assess the rates of Sustained Virological Response following anti-viral therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with recurrent Hepatitis C and treated with Neoral or tacrolimus.

Official Title

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

Stanford Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD

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

   - 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

   - 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

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mindie Nguyen, MD