Pilot Trial of Eculizumab Therapy to Reduce Preservation Injury in Human Macrosteatotic Liver Transplantation

EARLY_PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 1, 2021

Primary Completion Date

April 30, 2023

Study Completion Date

December 31, 2023

Conditions
End Stage Liver Disease
Interventions
DRUG

Eculizumab

Eculizumab will be given at a dose of 1200mg diluted in 0.9% sodium chloride (NaCl) to 5mg/mL for a total volume of 240 mL administered by IV infusion over 25-45 minutes in the anhepatic-phase during the transplant procedure, and a second dose of 900mg diluted in 0.9% NaCl to 5mg/mL for a total volume of 180 mL administered by IV infusion over 25-45 minutes will be given 24 hours following the first dose.

OTHER

No intervention

Historical control arm

Trial Locations (1)

70121

Ochsner Clinic Foundation, New Orleans

All Listed Sponsors
collaborator

Ochsner Health System

OTHER

collaborator

Alexion Pharmaceuticals, Inc.

INDUSTRY

lead

Yale University

OTHER