NCT00149994

Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients

DELTA Study Dutch Evaluation in Liver Transplantation To Assess the Efficacy of Cyclosporine A Microemulsion With C-2h Monitoring Versus Tacrolimus With Trough Monitoring in de Novo Liver Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In addition this study will assess the safety and tolerability of a cyclosporine A regimen based on C-2h monitoring in comparison to the standard tacrolimus regimen.

Conditions

• Liver Transplant

Interventions

Type	Name	Description
DRUG	Cyclosporine A
DRUG	Tacrolimus
DRUG	Basiliximab	Each patient was given two 20mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery.
DRUG	Methylprednisolone	Methylprednisolone was given as an intravenous bolus of 500mg during transplant surgery
DRUG	Prednisone	Post-operatively prednisone was tapered from an initial dose of 20mg/day to zero at 3 months or continued at 5-10mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.

Timeline

• Start date: 2002-12-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-09-08
• Last updated: 2011-04-12
• Results posted: 2011-02-14

Locations

1 site across 1 country: Switzerland