Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation

Primary Liver Transplant Clinical Trial

Official title:

Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation Following Campath-1H Induction

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00849238
• Other study ID #: H-2005-0291
• Secondary ID: CEL
• Status: Withdrawn
• Phase: N/A
• First received: December 14, 2007
• Last updated: October 6, 2015

Study information

• Verified date: October 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Primary Liver Transplant

Intervention

Drug:
• mycophenolate mofetil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison