Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

Study Overview
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Brief Summary
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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.

Detailed Description
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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 immunosuppression therapy.

Official Title
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A Single Center, Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients Utilizing a Tacrolimus/Mycophenolate Mofetil Based Maintenance Immunosuppression Protocol

Conditions
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Liver Transplantation

Intervention / Treatment
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* Drug: tacrolimus
* Drug: mycophenolate mofetil
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunosuppression<br>All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short course of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days. | Drug: tacrolimus<br>* Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.<br>* Other names: Prograf, FK506;Drug: mycophenolate mofetil<br>* Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.<br>* Other names: MMF, CellCept;Drug: Prednisone<br>* Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.<br>* Other names: corticosteriods;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Biopsy Confirmed Acute Rejection at 12 Months. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Survival. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MMF, Liver, Transplant, Corticosteroid withdrawal, Tacrolimus, CellCept, Mycophenolate mofetil