NCT01128335 - Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients | Biotech Hunter

Enrollment

200

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions

Liver Transplantation

Interventions

DRUG

MMF(1000mg bid) + tacrolimus + standard of care medications

DRUG

sotrastaurin (200mg bid) + tacrolimus + standard of care medications

DRUG

sotrastaurin (200mg bid) + tacrolimus + standard of care medications

DRUG

sotrastaurin (300 mg bid) + tacrolimus + standard of care medications

Trial Locations (39)

3000

Novartis Investigative Site, Leuven

8091

Novartis Investigative Site, Zurich

9000

Novartis Investigative Site, Ghent

13353

Novartis Investigative Site, Berlin

15006

Novartis Investigative Site, A Coruña

20162

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

30625

Novartis Investigative Site, Hanover

33076

Novartis Investigative Site, Bordeaux

35128

Novartis Investigative Site, Padua

37044

Novartis Investigative Site, Chambray-lès-Tours

41013

Novartis Investigative Site, Seville

45147

Novartis Investigative Site, Essen

45219

Novartis Investigative Site, Cincinnati

46026

Novartis Investigative Site, Valencia

55455

Novartis Investigative Site, Minneapolis

55905

Novartis Investigative Site, Rochester

56124

Novartis Investigative Site, Pisa

67098

Novartis Investigative Site, Strasbourg

69120

Novartis Investigative Site, Heidelberg

75012

Novartis Investigative Site, Paris

75246

Novartis Investigative Site, Dallas

77030

Novartis Investigative Site, Houston

90095

Novartis Investigative Site, Los Angeles

93053

Novartis Investigative Site, Regensburg

94000

Novartis Investigative Site, Créteil

94143

Novartis Investigative Site, San Francisco

94805

Novartis Investigative Site, Villejuif

48202-2689

Novartis Investigative Site, Detroit

C1118AAT

Novartis Investigative Site, CABA

C1181ACH

Novartis Investigative Site, CABA

C1107BEA

Novartis Investigative Site, San Martín

A-6020

Novartis Investigative Site, Innsbruck

A-1090

Novartis Investigative Site, Vienna

N6A 4G5

Novartis Investigative Site, London

140 21

Novartis Investigative Site, Prague

656 91

Novartis Investigative Site, Brno

00029

Novartis Investigative Site, HUS

08907

Novartis Investigative Site, L'Hospitalet de Llobregat