Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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)

Details

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.

Keywords

Liver Transplant Rejection Liver transplantation de novo recipients deceased donor CFZ533 CNI-free immunosuppression Transplant rejection Tacrolimus Tacrolimus - MMF - corticosteroids

Eligibility

You can join if…

Open to people ages 18-70

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.

You CAN'T join if...

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.

Locations

  • Novartis Investigative Site accepting new patients
    San Francisco California 94143 United States
  • Novartis Investigative Site accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT03781414
Phase
Phase 2
Study Type
Interventional
Last Updated