A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients

PHASE3CompletedINTERVENTIONAL
Enrollment

188

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Liver Transplantation
Interventions
DRUG

tacrolimus

Arm 1 : tacrolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to month 6 post-transplantation. Arm 2 : tacolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to 16 weeks post-transplantation at the latest.

DRUG

everolimus

Arm 1: no everolimus Arm 2: everolimus (C0 6-10 ng/ml) from randomization to month 6 post-transplantation

DRUG

Basiliximab

Basiliximab was supplied to the participating centers as marketed, i.e. in packs containing one vial of 20-mg powder, and water for injection (WFI). 20 mg at D0 and D4

DRUG

Mycophenolic Acid

Dose of 1440 mg/day from transplantation to month 6 post- transplantation

DRUG

Corticosteroids

Administration of oral corticosteroid therapy was at the discretion of the centers according to their usual practice

Trial Locations (14)

13385

Novartis Investigative Site, Marseille

25030

Novartis Investigative Site, Besançon

31054

Novartis Investigative Site, Toulouse

33076

Novartis Investigative Site, Bordeaux

34295

Novartis Investigative Site, Montpellier

35033

Novartis Investigative Site, Rennes

37044

Novartis Investigative Site, Chambray-lès-Tours

38043

Novartis Investigative Site, Grenoble

59037

Novartis Investigative Site, Lille

75651

Novartis Investigative Site, Paris

92110

Novartis Investigative Site, Clichy

94010

Novartis Investigative Site, Créteil

94800

Novartis Investigative Site, Villejuif

06202

Novartis Investigative Site, Nice

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY