Siplizumab for Autoimmune Liver Disease Patients Undergoing Liver Transplant

This study is testing a drug called Siplizumab in people with autoimmune liver diseases (like autoimmune hepatitis and primary sclerosing cholangitis) who are having a liver transplant. Siplizumab is a type of medicine called a monoclonal antibody that targets certain immune cells to help prevent the body from rejecting the new liver. Researchers want to see how safe Siplizumab is when given right after a liver transplant. The study plans to include up to 8 participants. The main goal is to track any serious infections in the first month after transplant. To join, you must be at least 18 years old, have one of these autoimmune liver diseases, be listed for a liver transplant, and have tested positive for Epstein-Barr virus (EBV) in the last year. The study status is currently unclear.

Study design
This is an open-label study, meaning both you and the study team will know you are receiving Siplizumab. It plans to include up to 8 participants.
What's involved
You would receive Siplizumab intravenously (through a vein) on the day of your transplant and again four days later. Your participation will last approximately 15 months, including time on the transplant waitlist and up to 12 months after your transplant.
Compensation
Not stated in the trial record.
Follow-up
The study will measure serious infections in the first month after your transplant. Your participation will last up to 12 months post-transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06455280

A Study of SIPLIZUMAB in AILD and LT Patients

Recruiting
PHASE1Ages 18+InterventionalTreatment
Elizabeth C. Verna
~8 participants
Updated 2025-11-24 on ClinicalTrials.gov
What's tested:Siplizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Serious infection in the first month post-transplant,
Measured over 1 Month post-transplant
Autoimmune Liver Disease
Liver Transplant Disorder
Autoimmune Hepatitis
Primary Sclerosing Cholangitis
End Stage Liver DIsease
Cirrhosis, Liver
1 sites across 1 states
New York1
  • Elizabeth Verna, MD · PRINCIPAL_INVESTIGATOR · Columbia University Irving Medical Center/ New York Presbyterian Hospital

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  • Serious infection in the first month post-transplant,1 Month post-transplant

    viral, bacterial or fungal infection that leads to readmission, prolonged hospitalization, reoperation, intensive care unit admission, graft loss or death.