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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2027
  • participants needed
    128
  • sponsor
    Novartis Pharmaceuticals
Updated on 19 September 2021

Summary

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.

Description

This study will allow assessment of the ability of CFZ533 to replace Calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing potentially better renal function with an expected similar safety and tolerability profile. Results of this study will be used to inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development.

Details
Condition Liver Transplant Rejection
Treatment CFZ533, Tacrolimus - MMF - corticosteroids
Clinical Study IdentifierNCT03781414
SponsorNovartis Pharmaceuticals
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

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/mm or white blood cell count of < 2,000/mm
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
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