Mycophenolate Mofetil Immunosuppression Without/With Reduced Dose Calcineurin Inhibitor Long After Liver Transplantation

Inclusion Criteria

• Male or female 18 years of age or older (females who can become pregnant must use two acceptable methods of birth control while taking mycophenolate mofetil)
• Orthotopic liver transplant more than one year prior to enrollment
• Using calcineurin inhibitor to prevent rejection at time of screening
• Patients must be willing to provide informed consent and abide by the requirements of the study

Exclusion Criteria

• Liver disease may not have been secondary to an autoimmune cause, including:
• autoimmune hepatitis,
• primary sclerosing cholangitis,
• primary biliary cirrhosis
• Patients who have had:
• more than one prior episode of rejection,
• rejection within the past six months,
• any corticosteroid resistant rejection
• Patients with a tacrolimus trough level of greater than 7 ng/ml within 90 days prior to enrollment
• Patients with a cyclosporine trough level greater than 225 ng/ml within 90 days prior to enrollment
• Patients taking more the 5 mg per day of prednisone within 90 days prior to enrollment
• Patients taking any prednisone within 30 days of enrollment
• Allograft dysfunction within 6 months of enrollment, including ALT and/or total bilirubin greater than 2x normal, and/or biopsy proven hepatitis C virus (HCV) with fibrosis greater than stage II
• White blood cell count less than 2,500 or platelet count less than 50,000 within 60 days of enrollment
• MPA AUC threshold: Patients are not eligible for the study if they do not attain the threshold value MPA AUC (>30 mg*h/L if on CsA, >40 mg*h/L if on tacrolimus) after 50% calcineurin inhibitor reduction, measured using a 3-sample estimate (trough, 30-min, 120-min)
• Patients who have had a previous transplant of organ(s) other than liver
• Patients who received a liver from a hepatitis C positive donor
• Patients who received a liver from a living donor
• Patients with any technical complication requiring intervention within the three months prior to screening
• Current infection requiring treatment
• History of post transplant lymphoproliferative disorder
• History of malignancy other than non-melanoma skin cancer or Stage 1-2 hepatoma
• Active or unhealed duodenal ulcer
• Concomitant treatment with rapamycin and/or interferon
• Known allergy or sensitivity to CellCept® or any of its components
• Unable or unwilling to comply with the protocol requirements or considered by the investigator(s) to be unfit for the study
• Participation in a clinical trial within 30 days prior to study entry or prior enrollment in any CellCept® clinical trial
• Pregnant or breastfeeding woman
• Diabetes with known, clinically significant gastroparesis