Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.

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

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Astellas Pharma Inc
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Tacrolimus

Criteria

Inclusion Criteria:

• Greater than 90 days post transplant.

• Free from rejection within the last 30 days.

• Patient with primary diagnosis of AIH will be evaluated on an individual basis.

• Negative pregnancy test.

• Practicing an acceptable method of birth control.

• Capable of providing written informed consent.

Exclusion Criteria:

• Rejection within the last 30 days.

• Patients with AIH unable to discontinue corticosteroids.

• Patients currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation is contraindicated.

• Known sensitivity or contraindication to tacrolimus or MMF.

• Kidney, pancreas, islet, heart, lung, or small bowel transplant recipient.

• Pregnant or lactating.