An Open, Randomised, Multicenter, Clinical Study to Compare the Safety and Efficacy of Tacrolimus and Minimal Steroids in Combination With Either a Monoclonal Anti-IL2R Antibody (Daclizumab) or Mycophenolate Mofetil in Liver Allograft Transplantation. (MARSILEA)

NCT00295594 Phase 3 COMPLETED

To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.

Details

Lead sponsor	Astellas Pharma Inc
Phase	Phase 3
Status	COMPLETED
Enrolment	627
Start date	2005-03
Completion	2007-06

Conditions

• Liver Transplantation

Interventions

• tacrolimus

Primary outcomes

• Incidence of and time to first biopsy proven acute rejection which requires treatment within 3 months following transplantation — 3 months

Countries

Belgium, Denmark, Finland, Germany, Hungary, Italy, Poland, Spain, Sweden, Switzerland, United Kingdom