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
Stopped early · Phase 2
Conditions studied: Liver Transplant Rejection
In brief
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.
Key facts
- Study ID
- NCT03781414
- Run by
- Novartis Pharmaceuticals
- People needed
- 129
- Starts
- 2019-10-07
- Expected to finish
- 2023-04-20
- Last updated by the study team
- 2025-05-16
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Southern California — Los Angeles, California, United States
- University of Colorado Hospital - Aurora — Aurora, Colorado, United States
- Northwestern University — Chicago, Illinois, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Wash U School of Medicine — St Louis, Missouri, United States
- Duke Univ Medical Center — Durham, North Carolina, United States
- University Of Cincinnati — Cincinnati, Ohio, United States
- Medical University of South Carolina MUSC — Charleston, South Carolina, United States
- The Methodist Hospital — Houston, Texas, United States
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — Caba, Buenos Aires, Argentina
- Novartis Investigative Site — Ghent, Belgium
- Novartis Investigative Site — Prague, Czechia
- Novartis Investigative Site — Chambray-lès-Tours, France
- Novartis Investigative Site — Lille, France
- Novartis Investigative Site — Montpellier, France
- Novartis Investigative Site — Villejuif, France
- Novartis Investigative Site — Regensburg, Bavaria, Germany
- Novartis Investigative Site — Berlin, Germany
- Novartis Investigative Site — Hamburg, Germany
- Novartis Investigative Site — Münster, Germany
- Novartis Investigative Site — Budapest, Hungary
- Novartis Investigative Site — Pisa, PI, Italy
- Novartis Investigative Site — Rotterdam, South Holland, Netherlands
Full record on ClinicalTrials.gov
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