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

Withdrawn before enrolling · Early Phase 1

Conditions studied: End Stage Liver Disease

In brief

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 not used for transplants, due to increased risk of adverse events and deaths post-transplant. The investigators propose administering eculizumab to patients receiving macrosteatotic liver transplants and hypothesize that doing so will mitigate post-surgical adverse outcomes.

Key facts

Study ID

NCT03468140

Run by

Yale University

People needed

0

Starts

2021-10-01

Expected to finish

2023-12-31

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%

Where it is running

• Ochsner Clinic Foundation — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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