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

• Status: Withdrawn
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: Alexion Pharmaceuticals; Ochsner Health System
• Treatments: Eculizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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%