Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation

NCT ID: NCT00849238

Last Updated: 2015-10-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

Brief Summary

The rationale for this study is to determine if Campath-1H can be used in liver transplant recipients to induce a state of immunological unresponsiveness that would not only eliminate the need for calcineurin inhibitors maintenance therapy, but also reduce corticosteroids utilization, decreasing the incidence of acute cellular rejection and perhaps reduce the severity of histologic recurrence of certain autoimmune diseases responsible for causing liver failure. The investigator propose a randomized prospective open label trial in 50 liver transplant recipients who will received a calcineurin inhibitors free immunosuppressive protocol that consist of a single dose of Campath-1H as an induction therapy in association with maintenance mycophenolate mofetil (CellCept®) and low dose steroids. The second group will receive a standard immunosuppressive regimen, which consists of IV steroid induction therapy and maintenance steroids, together with tacrolimus at a full therapeutic dose with no induction antibody therapy.

Conditions

Primary Liver Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

mycophenolate mofetil

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects;

2. Ages 45 years and older;

3. Are to receive a liver transplant.

Exclusion Criteria

1. Recipients of a multi-organ transplant;

2. known hypersensitivity to daclizumab, CellCept®, or prednisone;

3. therapy with an investigational medication within 4 weeks of study entry;

4. history of malignancies within the past 5 years and/or lymphoma, excluding adequately treated skin carcinoma (basal or squamous cell), or other than exclusion #9;

5. history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study;

6. history of HIV infection;

7. females who are pregnant or nursing;

8. subject is receiving systemic corticosteroids for other medical conditions for which the physician feels that discontinuation of corticosteroids is contraindicated;

9. T2 or higher hepatocellular carcinoma

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CEL

Identifier Type: -

Identifier Source: secondary_id

H-2005-0291

Identifier Type: -

Identifier Source: org_study_id