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

A 12-month, Open-label, Multicenter, Randomized, Safety, Efficacy, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of an Anti-CD40 Monoclonal Antibody, CFZ533 vs. Standard of Care Control, in Adult de Novo Liver Transplant Recipients With a 12-month Additional Follow-up (CONTRAIL I)

ClinicalTrials.gov Identifier: NCT03781414

Novartis Reference Number: CCFZ533A2202

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 dose regimens in liver transplant recipients.

Condition 
Liver Transplant Rejection
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
128 participants
Start date 
Oct 07, 2019
Completion date 
Apr 26, 2023
Gender 
All
Age(s)
18 Years - 70 Years (Adult, Older Adult)

Interventions

Biological
CFZ533
Comparison with standard of care immunosuppression
Drug
Tacrolimus - MMF - corticosteroids
Standard of care immunosupprevive regimen

Eligibility Criteria

Inclusion Criteria:

Screening period up to liver transplantation: -Written informed consent obtained before any assessment.

Male or female subjects between 18 to 70 years of age.
Recipients of a primary liver transplant from a deceased donor.
Up to date vaccination as per local immunization schedules.
Recipients tested negative for HIV.
MELD score ≤30.

At randomization:

Recipients with no active HCV and HBV replication (no detectable RNA/DNA by PCR).
Allograft is functioning at an acceptable level by the time of randomization as defined by AST, ALT, Total Bilirubin, and Alkaline Phosphatase levels ≤ 5 times ULN.
Renal function (eGFR, MDRD-4 formula) ≥ 30 mL/min/1.73 m2 based on most recent post-transplant value prior to randomization.

Exclusion Criteria:

Screening period up to liver transplantation:

Recipients of a liver from a donor after cardiac death (DCD), from a living donor, or of a split liver.
A negative Epstein Barr virus (EBV) test.
Recipients receiving an ABO incompatible allograft.
History of malignancy of any organ system treated or untreated, within the past 5 years.
Hepatocellular carcinoma that does not fulfill Milan criteria.
Recipients transplanted for acute liver failure.
Any use of antibody induction therapy, or use of any immunosuppressive medications
Patients who have received a live vaccine within four weeks prior to transplantation.
Recipients with donors HIV positive, HBsAg positive, HCV positive.
Recipients with donors with hepatic steatosis > 30%.

At randomization:

Any post-transplant history of thrombosis, occlusion or stent placement in any hepatic arteries, hepatic veins, portal vein or inferior vena cava at any time during the run-in period prior to randomization.
Recipients with platelet count < 50,000/mm3, an absolute neutrophil count of < 1,000/mm³ or white blood cell count of < 2,000/mm³.
Recipients with clinically significant systemic infection requiring use of intravenous (IV) antibiotics.
Evidence of active tuberculosis (TB) infection.
Any episode of acute rejection or suspected rejection prior to randomization.

Study Locations

United States
Novartis Investigative Site
Recruiting
Boston, 02114
Massachusetts
United States
Novartis Investigative Site
Recruiting
Detroit, 48202
Michigan
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63110
Missouri
United States
Novartis Investigative Site
Recruiting
Durham, 27710
North Carolina
United States
Novartis Investigative Site
Recruiting
Cincinnati, 45267
Ohio
United States
Novartis Investigative Site
Recruiting
Charleston, 29425
South Carolina
United States
Novartis Investigative Site
Recruiting
Dallas, 75246
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77030
Texas
United States
Novartis Investigative Site
Recruiting
Seattle, 98195
Washington
United States
Belgium
Novartis Investigative Site
Recruiting
Bruxelles, 1070
-
Belgium
Novartis Investigative Site
Recruiting
Gent, 9000
-
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Czechia
Novartis Investigative Site
Recruiting
Praha 4, 140 21
Czech Republic
Czechia
France
Novartis Investigative Site
Recruiting
Chambray les Tours, 37044
-
France
Novartis Investigative Site
Recruiting
Lille Cedex, 59 037
-
France
Novartis Investigative Site
Recruiting
Montpellier, 34295
-
France
Novartis Investigative Site
Recruiting
Paris Cedex 13, 75651
-
France
Novartis Investigative Site
Recruiting
Rennes, 35043
-
France
Novartis Investigative Site
Recruiting
Villejuif, 94805
-
France
Germany
Novartis Investigative Site
Recruiting
Regensburg, 93053
Bavaria
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20246
-
Germany
Novartis Investigative Site
Recruiting
Kiel, 24105
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Muenster, 48149
-
Germany
Novartis Investigative Site
Recruiting
Tübingen, 72076
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1082
-
Hungary
Italy
Novartis Investigative Site
Recruiting
Bergamo, 24128
BG
Italy
Novartis Investigative Site
Recruiting
Pisa, 56124
PI
Italy
Netherlands
Novartis Investigative Site
Recruiting
Rotterdam, 3015 CE
-
Netherlands
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41013
Andalucia
Spain
Novartis Investigative Site
Recruiting
Valladolid, 47012
Castilla Y Leon
Spain
Novartis Investigative Site
Recruiting
L Hospitalet De Llobregat, 08907
Cataluna
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
Recruiting
Baracaldo, 48903
Vizcaya
Spain
United Kingdom
Novartis Investigative Site
Recruiting
London, SE5 9RS
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]