Steroid Free Immunosuppression in Liver Transplantation

Completed · Phase 4

Conditions studied: Liver Cirrhosis, Liver Transplant Disorder

In brief

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.

Key facts

Study ID

NCT00296244

Run by

Thomas Jefferson University

People needed

40

Starts

2006-02-01

Expected to finish

2008-06-01

Last updated by the study team

2012-11-19

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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