Status:
WITHDRAWN
Pilot Trial of Eculizumab Therapy to Reduce Preservation Injury in Human Macrosteatotic Liver Transplantation
Lead Sponsor:
Yale University
Collaborating Sponsors:
Ochsner Health System
Alexion Pharmaceuticals, Inc.
Conditions:
End Stage Liver Disease
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The number of liver transplants that can be performed is limited by the availability of organs. Livers that are steatotic (i.e., infiltrated by triglycerides and other fatty substances) are usually no...
Detailed Description
Mortality from liver disease accounts for approximately 34,000-36,000 annualized deaths and represents 11.5 deaths per 100,000 persons in the United States(1). Liver transplant is the only established...
Eligibility Criteria
Inclusion
- Age\>18, weight\>40kg
- Recipients of first liver transplant
- Biopsy proven macrosteatosis of \> or = 20%
- Cold ischemia time \< 8 hours
- Recipients of brain-dead deceased donors
Exclusion
- Dual organ transplants
- ABO incompatible
- Meningococcal vaccination refusal
- Dual barrier contraception refusal
- Recipients with acute liver failure
- Recipients with Hepatitis B or C viral loads
- Physiological MELD Score\>35
- Donor liver biopsy showing combined Microsteatosis+Macrosteatosis\>70%
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03468140
Start Date
October 1 2021
End Date
December 31 2023
Last Update
April 8 2021
Active Locations (1)
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1
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121