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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the safety and efficacy of mycophenolate mofetil alone, or with reduced dose cyclosporine (CsA) or tacrolimus, for immunosuppression long-term after liver transplantation, in an attempt to reduce the potential side effects from using cyclosporine or tacrolimus.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein Healthcare Network
• Collaborator: Hoffmann-La Roche
• Treatments: Calcineurin Inhibitors; Mycophenolate mofetil; Mycophenolic Acid

Criteria

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