Steroid Free Immunosuppression in Liver Transplantation

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether steroid-related complications can be avoided by using steroid-free immuno-suppressive drug regimen after liver transplantation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborator: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Basiliximab; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Tacrolimus

Criteria

Inclusion Criteria:

• Male and female patients between 18 and 72 years of age

• Male or female patients who are primary cadaveric liver transplant recipients

• Cold ischemia time must be <20 hours

• Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication

• Patient has given written informed consent to participate in the study

Exclusion Criteria:

• Patients meeting any of the following criteria at baseline will be excluded from study participation

• Patients who have previously received an organ transplant

• Patients who are recipients of a multiple organ transplants

• Women of childbearing potential not using the contraception method(s) specified in this study, as well as women who are breastfeeding

• Known sensitivity to Simulect or class of Simulect

• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study

• Use of any other investigational agent in the last 30 days