CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Steroids +3 moredrug
Likely dose
Steroids 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00296244
NCT00296244Phase 4Completed
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Steroid Free Immunosuppression in Liver Transplantation

Thomas Jefferson University·interventional·Posted Feb 24, 2006·Updated Nov 19, 2012

In Brief

A Phase 4 clinical trial evaluating Steroids, Basiliximab, and 2 other interventions for Liver Cirrhosis and Liver Transplant Disorder. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cirrhosis, Liver Transplant Disorder
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 24, 2006
Enrollment StartFeb 1, 2006
Primary CompletionMay 1, 2008
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.4 years ago

Interventions

Steroidsdrug

Patients randomized to Control group shall be administered steroids as methylprednisolone (Solumedrol) 1000 mg IV during the anhepatic phase. Methylprednisolone will be continued according to the following taper schedule: 50 mg IV every 6 hrs on day 1; 40 mg IV every 6hrs on day 2; 30 mg IV every 6 hrs on day 3; 20 mg IV every 6 hrs on day 4; 20 mg IV every 12 hrs on day 5; and Prednisone 20 mg by mouth or Naso-gastric tube (NGT) on day 6. Prednisone shall be tapered slowly starting at 1 month post-OLT and weaned off completely by 6 months post-OLT.

Basiliximabdrug

Basiliximab shall be given as induction therapy at 20 mg IV bolus intra-operatively and on the 4th day after transplantation.

Tacrolimusdrug

Tacrolimus shall be used as the main maintenance immuno-suppressive drug. It will be given at a dose of 0.15mg/ kg/ day by mouth or through a naso-gastric tube (NGT), starting not earlier than 24 after the transplant but within 48 hrs after reperfusion. The dose shall be adjusted to achieve a trough level of 10-15 ng/ml during the first 30 days after transplantation and lowered to 5-10 ng/ml, thereafter.

Enteric-coated Mycophenolic acid (EC-MPA)drug

This drug may be given in combination with calcineurin inhibitors (tacrolimus) and steroids for maintenance immuno-prophylaxis to prevent rejection. They are particularly useful in recipients with renal dysfunction and neurotoxicity, when there is a need to reduce dose or delay introduction of calcineurin inhibitors. This drug is given at 720 mg PO BID for 3 months.