MedTrace Logo

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

NCT03781414 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2025-05-16

Study results available
· View outcomes & findings →

Summary

This was a multicenter, open-label, active-controlled study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 maintenance doses in de novo liver transplant recipients.

Conditions

  • Liver Transplant Rejection

Interventions

BIOLOGICAL

CFZ533

Comparison with standard of care immunosuppression

DRUG

Tacrolimus - MMF - corticosteroids

Standard of care immunosuppresive regimen

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2023-04-20
Completion
2023-04-20
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03781414 on ClinicalTrials.gov