Phase 4
N=40
Steroid Free Immunosuppression in Liver Transplantation
Liver Cirrhosis · Liver Transplant Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00296244 ↗Enrolled (actual)
40
Serious AEs
12.8%
Results posted
Nov 2012
Primary outcome: Primary: Graft Survival Rate — 100; 94.7; 90; 84 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Steroids (Drug); Basiliximab (Drug); Tacrolimus (Drug); Enteric-coated Mycophenolic acid (EC-MPA) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Graft Survival Rate |
100; 94.7; 90; 84 | — |
| PRIMARY Patient Survival Rate |
100; 94.7; 90; 84 | — |
| PRIMARY Acute Rejection Rate |
5; 5 | — |
| SECONDARY Infection as an Adverse Effect of Steroids |
20; 21 | — |
| SECONDARY Incidence and Severity of HCV Recurrence Post-OLT |
27; 29 | — |
| SECONDARY New-onset Diabetes Mellitus (NODM) as Secondary Outcome |
40; 42 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00296244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.