Status:
COMPLETED
Steroid Free Immunosuppression in Liver Transplantation
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Liver Cirrhosis
Liver Transplant Disorder
Eligibility:
All Genders
18-72 years
Phase:
PHASE4
Brief 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.
Detailed Description
Steroids have remained a standard part of post-transplant immunosuppression, both for prevention and treatment of rejection. However, steroids have been shown to cause long-term adverse effects, such ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00296244
Start Date
February 1 2006
End Date
June 1 2008
Last Update
November 19 2012
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107