Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

Completed · Phase 4

Conditions studied: Liver Transplantation

In brief

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.

Key facts

Study ID

NCT00374231

Run by

University of Cincinnati

People needed

40

Starts

2002-10-01

Expected to finish

2008-01-01

Last updated by the study team

2015-12-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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