Thymoglobulin Use in Liver Transplant Patients

Pharmacodynamics, Pharmacogenomics and Preliminary Safety and Efficacy of rATG Induction and Tacrolimus Monotherapy in Pediatric Liver Transplantation

Protocol Description

This research study is taking a look at a new combination of medicines used in liver transplantation to see how they work to prevent rejection. Traditional combinations of tacrolimus plus steroids can cause suppression of the function of lymphocytes, delayed growth and development of bones. In this study, both the traditional combination and the introduction of thymoglobulin used with tacrolimus in place of steroids will be used.

Eligibility Criteria

Eligible candidates will include males and females, under 21 years of age, who are about to receive a liver transplant.
Males: 21 years and younger
Females: 21 years and younger

Requirements

Participants will undergo various routine procedures for transplant patients, including blood draws, while receiving either the newer combination or the traditional combination of anti-rejection drugs throughout the study duration.
Visits: Multiple, as with conventional post-transplant care
Duration: 1 year

Status: Open for Enrollment

Source(s) of Support

Genzyme Corporation
National Institutes of Health
Pediatric Transplantation Department, Children’s Hospital of Pittsburgh of UPMC

Primary Investigator

Rakesh Sindhi, MD

Contact Information

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