OPTIMAL Trial Has Completed Enrollment

Enrollment in the ITN056ST OPTIMAL trial is officially completed with the accrual of the 61st participant as of February, 2019. A total of 100 liver transplant recipients were enrolled from 7 major US transplant centers: Northwestern, UCSF, Massachusetts General Hospital, University of Pittsburgh, Columbia, Baylor, and UPenn. The 61 participants who went on to qualify for accrual into the trials were those who met the additional trial criteria for liver function and histology.

The study team has already had one abstract accepted for presentation at the American Transplant Congress (ATC) in 2017, Subclinical Inflammation is Observed in 1 in 4 Stable Adult Liver Transplant Recipients Screened for Immunosuppression Withdrawal (ISW): OPTIMAL Study. Another abstract that focuses on entry biopsy findings has has been accepted and will be presented at the ATC meeting on June 4th, Inflammation and Fibrosis is Observed in 34% of Clinically Stable Adult Liver Transplant Recipients.

The OPTIMAL trial opened in early 2016 as an immunosuppression withdrawal (ISW) trial in liver transplant recipients who were at least 6 years post-transplant if 18-50 years old, or at least 3 years post-transplant if older. The primary aim of this study is to determine whether markers of immune senescence or exhaustion are different between operationally tolerant and non-tolerant liver transplant recipients. This trial built on our experience with the ITN029ST WISPR and ITN823ST iWITH studies of IS withdrawal in pediatric liver transplant recipients as well as the ITN030ST AWISH IS withdrawal study in adults. The mechanistic hypothesis also has its roots in work done by Alberto Sanchez-Feuyo  and in fact the trial was designed in parallel with Sanchez-Feuyo’s LIFT Trial which is based at King’s College, London and is being conducted in the UK and Europe.

Liver transplant recipients must take anti-rejection medication (immunosuppression) for the rest of their lives. If they stop, their immune system may reject the transplanted liver. However, anti-rejection medications have many unwanted side effects. Because of the side effects of anti-rejection medications, an important goal of transplant research is to allow people to accept their transplanted organ without long term use of anti-rejection medications. OPTIMAL study participants have their anti-rejection medication(s) gradually reduced over a period of time and then stopped.

The purpose of this research study is to learn how many liver transplant recipients will develop tolerance after immunosuppression withdrawal. The researchers also want to find out if there are blood or liver biopsy tests that can help transplant doctors in the future predict whether it is safe to decrease or stop anti-rejection medications in people who received a liver transplant.