Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation

NCT00849238 | Withdrawn

• 2 other identifiers: H-2005-0291CEL
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Interventions

mycophenolate mofetil DRUG

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects;
• Ages 45 years and older;
• Are to receive a liver transplant.

You may not qualify if:

• Recipients of a multi-organ transplant;
• known hypersensitivity to daclizumab, CellCept®, or prednisone;
• therapy with an investigational medication within 4 weeks of study entry;
• history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study;
• history of HIV infection;
• females who are pregnant or nursing;
• subject is receiving systemic corticosteroids for other medical conditions for which the physician feels that discontinuation of corticosteroids is contraindicated;
• T2 or higher hepatocellular carcinoma

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: February 23, 2009
• Last Updated: October 8, 2015

Record last verified: 2015-10