Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2015-09-30

Brief Summary

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In order to prevent organ rejection, patients receiving liver transplants currently require life-long treatment with immune system-suppressing medications to prevent the rejection of the transplanted liver. However, these medications can cause long-term side effects, such as infection, kidney problems, diabetes, and cancer. In patients infected with hepatitis C virus (HCV), these medications may increase the risk of HCV infection in the transplanted liver. The purpose of this study is to determine whether a slow withdrawal of immune system-suppressing medications is safe in two groups of subjects: those who receive a liver transplant due to HCV, and those who receive a liver transplant due to non-immune, non-viral causes of liver failure. The study will also look at whether slow withdrawal will help reduce the long-term side effects of immune system-suppressing medications and decrease the chance for HCV infection of the new liver in transplant patients with HCV.

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Detailed Description

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This is a prospective multicenter, open-label, randomized trial in which individuals with liver failure due to hepatitis C or to nonimmune nonviral causes undergo liver transplantation and receive immunosuppression with a calcineurin inhibitor and corticosteroids. Corticosteroids are tapered in the 3 months after transplantation and the calcineurin inhibitor is continued. Participants are regularly assessed for evidence of allograft rejection. One year after transplantation, participants eligible for withdrawal are randomly assigned in a 4 to 1 ratio to immunosuppression withdrawal or to maintenance. Participants assigned to withdrawal undergo a scheduled taper over approximately 1 year.

Conditions

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Hepatitis C Hepatitis C, Chronic Nonimmune Nonviral Causes of Liver Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immunosuppression Withdrawal

Subjects may randomize to this group at 12 to 24 months after transplantation. This is followed by tapered withdrawal of calcineurin inhibitor-based immunosuppression therapy over the course of 1 year.

Group Type EXPERIMENTAL

calcineurin inhibitor-based immunosuppression

Intervention Type DRUG

May be cyclosporine, mycophenolate mofetil, or tacrolimus

liver transplant

Intervention Type PROCEDURE

Occurs at study entry

corticosteroids

Intervention Type DRUG

3-month course of corticosteroids

immunosuppression withdrawal

Intervention Type OTHER

One year after transplantation, participants eligible for withdrawal are randomly assigned in a 4 to 1 ratio to immunosuppression withdrawal or to maintenance.

Immunosuppression Maintenance

Liver transplant, followed by maintenance doses of continuous calcineurin inhibitor-based immunosuppression therapy.

Group Type ACTIVE_COMPARATOR

calcineurin inhibitor-based immunosuppression

Intervention Type DRUG

May be cyclosporine, mycophenolate mofetil, or tacrolimus

liver transplant

Intervention Type PROCEDURE

Occurs at study entry

corticosteroids

Intervention Type DRUG

3-month course of corticosteroids

Interventions

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calcineurin inhibitor-based immunosuppression

May be cyclosporine, mycophenolate mofetil, or tacrolimus

Intervention Type DRUG

liver transplant

Occurs at study entry

Intervention Type PROCEDURE

corticosteroids

3-month course of corticosteroids

Intervention Type DRUG

immunosuppression withdrawal

One year after transplantation, participants eligible for withdrawal are randomly assigned in a 4 to 1 ratio to immunosuppression withdrawal or to maintenance.

Intervention Type OTHER

Other Intervention Names

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liver transplantation prednisone

Eligibility Criteria

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Inclusion Criteria

1. Male or female 18 years of age or older.
2. Necessity for liver transplant.
3. For females of childbearing potential: a negative pregnancy test at study entry and agreement to use approved methods of birth control for the duration of their participation.
4. Ability to provide informed consent.
5. Availability of donor specimen(s).
6. For individuals with hepatitis C infection, presence of hepatitis genomes in blood.

Exclusion Criteria

1. Previous transplant.
2. Multiorgan or split liver transplant other than with a right trisegment.
3. Living donor transplant.
4. Donor liver from a donor positive for antibody against hepatitis C.
5. Donor liver from a non-heart-beating donor.
6. Liver failure due to autoimmune disease.
7. Fulminant liver failure.
8. Hepatitis B infection as defined by the presence of HbSAg or hepatitis-C infection with a genome other than genome 1.
9. Stage III or higher hepatocellular cancer.
10. History of malignancy except hepatocellular cancer, adequately treated in situ cervical carcinoma,adequately treated basal or squamous cell carcinoma of skin, or other cancer judged to have a 5-year risk of recurrence less than 10%.
11. Active systemic infection at the time of transplantation.
12. Clinically significant chronic renal disease.
13. Clinically significant cardiovascular or cerebrovascular disease.
14. Infection with human immunodeficiency virus.
15. Any investigational drug received within 6 weeks of study entry or any investigational vaccine received at any time.
16. Hypersensitivity to tacrolimus.
17. Unwillingness or inability to comply with study requirements.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No