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Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

NCT ID: NCT00374231

Last Updated: 2015-12-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2008-01-31

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.

Conditions

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Liver Transplantation

Keywords

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Liver Transplant Corticosteroid withdrawal Tacrolimus CellCept MMF Mycophenolate mofetil

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immunosuppression

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.

Group Type EXPERIMENTAL

tacrolimus

Intervention Type DRUG

Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

mycophenolate mofetil

Intervention Type DRUG

Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Prednisone

Intervention Type DRUG

Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Interventions

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tacrolimus

Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Intervention Type DRUG

mycophenolate mofetil

Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Intervention Type DRUG

Prednisone

Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Intervention Type DRUG

Other Intervention Names

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Prograf, FK506 MMF, CellCept corticosteriods

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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E. Steve Woodle

MD, FACS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steve Woodle, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CSWD Liver

Identifier Type: -

Identifier Source: org_study_id