Immunosuppressive Drugs and Liver Transplants

In Vitro Correlates of Transplant Tolerance in Children Off Immunosuppression

Protocol Description

Despite recent major advances in organ transplants, patients receiving transplanted organs must often remain on immunosuppressive (anti-rejection) medication for the rest of their lives. The purpose of this study is to evaluate the accuracy of certain research blood tests – both genetic blood tests and immunologic blood tests – which may help tell which liver transplant patients can stop taking immunosuppressive drugs without rejecting their newly transplanted livers.

Eligibility Criteria

This research study will focus on 4 groups of liver transplant recipients:

  • Those who have stopped taking immunosuppressive drugs and who show no sign of rejecting their transplanted liver.
  • Those who have attempted to stop taking immunosuppressive drugs but who have shown signs of rejection.
  • Those who have not attempted to stop taking immunosuppressive drugs but have shown signs of rejection.
  • Those currently enrolled in a liver transplant protocol in which immunosuppression has been initiated, and for whom an attempt to withdraw immunosuppression will be made in the future as part of the standard care of the transplant patients.

Females: All ages
Males: All ages

Requirements

To study aspects of the participant's genetic make-up and immune system, blood samples will be taken – at the initial visit and again, 6 months later. Tests will evaluate how immune cells react and how the genetic code determines the response to the transplanted organ. Sample liver tissue will be collected, either from a biopsy that has already been done or which will be performed as part of the patient's normal care. This study does not involve any change in the routine clinical care or monitoring of the patient's post-transplant treatment.
Visits: 2 for blood sampling
Duration: 6 months

Status: Open to Enrollment

Source(s) of Support

Children's Hospital of Pittsburgh of UPMC

Primary Investigator

George Mazariegos, MD

Contact Information

For more information, please contact:
Katie Hindes Kalata, BS, MPH
412-692-8472
or
Kym Smith, BS
412-692-5297