Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.

PHASE3CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Renal FunctionLiver Transplant
Interventions
DRUG

Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.

Immunosuppression after liver transplantation. Pediatric transplant recipients received a starting dose of 0.8 mg/m\^2/dose in combination wit Cyclosporine A or 2.0 mg/m\^2/dose in combination with tacrolimus, twice-daily. Thereafter, doses were adjusted to achieve everolimus C-0h blood trough level between 3 to 8 ng/ml.

Trial Locations (32)

1082

Novartis Investigative Site, Budapest

1083

Novartis Investigative Site, Budapest

1200

Novartis Investigative Site, Brussels

3052

Novartis Investigative Site, Parkville

10126

Novartis Investigative Site, Torino

20246

Novartis Investigative Site, Hamburg

24128

Novartis Investigative Site, Bergamo

28046

Novartis Investigative Site, Madrid

29425

Novartis Investigative Site, Charleston

30625

Novartis Investigative Site, Hanover

35128

Novartis Investigative Site, Padua

45147

Novartis Investigative Site, Essen

53105

Novartis Investigative Site, Bonn

53792

Novartis Investigative Site, Madison

60637

Novartis Investigative Site, Chicago

63110

Novartis Investigative Site, St Louis

69677

Novartis Investigative Site, Bron

72076

Novartis Investigative Site, Tübingen

84132

Novartis Investigative Site, Salt Lake City

90027

Novartis Investigative Site, Los Angeles

93053

Novartis Investigative Site, Regensburg

110032

Novartis Investigative Site, New York

06520

Novartis Investigative Site, New Haven

77030-2400

Novartis Investigative Site, Houston

T6G 2B7

Novartis Investigative Site, Edmonton

DK-2100

Novartis Investigative Site, København Ø

00165

Novartis Investigative Site, Roma

08035

Novartis Investigative Site, Barcelona

SE-141 86

Novartis Investigative Site, Stockholm

B4 6NH

Novartis Investigative Site, West Midlands

LS1 3EX

Novartis Investigative Site, Leeds

SE5 9RS

Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY