Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension

PHASE2TerminatedINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

October 7, 2019

Primary Completion Date

April 20, 2023

Study Completion Date

April 20, 2023

Conditions
Liver Transplant Rejection
Interventions
BIOLOGICAL

CFZ533

Comparison with standard of care immunosuppression

DRUG

Tacrolimus - MMF - corticosteroids

Standard of care immunosuppresive regimen

Trial Locations (29)

9000

Novartis Investigative Site, Ghent

13353

Novartis Investigative Site, Berlin

20246

Novartis Investigative Site, Hamburg

27710

Duke Univ Medical Center, Durham

28009

Novartis Investigative Site, Madrid

29425

Medical University of South Carolina MUSC, Charleston

34295

Novartis Investigative Site, Montpellier

37170

Novartis Investigative Site, Chambray-lès-Tours

41013

Novartis Investigative Site, Seville

45267

University Of Cincinnati, Cincinnati

48149

Novartis Investigative Site, Münster

56124

Novartis Investigative Site, Pisa

59037

Novartis Investigative Site, Lille

60611

Northwestern University, Chicago

63110

Wash U School of Medicine, St Louis

77030

The Methodist Hospital, Houston

80045

University of Colorado Hospital - Aurora, Aurora

90033

University of Southern California, Los Angeles

93053

Novartis Investigative Site, Regensburg

94805

Novartis Investigative Site, Villejuif

48202 2689

Henry Ford Hospital, Detroit

C1118AAT

Novartis Investigative Site, CABA

C1181ACH

Novartis Investigative Site, CABA

C1280AEB

Novartis Investigative Site, Caba

146 24

Novartis Investigative Site, Prague

H-1083

Novartis Investigative Site, Budapest

3015 GD

Novartis Investigative Site, Rotterdam

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

08036

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY