Status:
COMPLETED
rATG Induction and Tacrolimus Monotherapy in Pediatric Liver Transplantation
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Liver Transplantation
Thymoglobulin
Eligibility:
All Genders
Up to 21 years
Brief Summary
This open-label clinical trial will evaluate the pharmacodynamics, pharmacogenomics and early efficacy and safety of steroid-free Tacrolimus (TAC) monotherapy and its minimization after induction with...
Detailed Description
This open-label clinical trial will evaluate the pharmacodynamics, pharmacogenomics and early efficacy and safety of steroid-free Tacrolimus (TAC) monotherapy and its minimization after induction with...
Eligibility Criteria
Inclusion
- Age 0-21 years, male and female
- Primary OLTx, Whole/segmental, cadaveric/live, Re-LTx, and LTx in the setting of a previous or simultaneous kidney transplant.
- All children receiving the types of LTx described above, but on conventional immunosuppression, will be enrolled in an observational arm, with the same treatment and monitoring protocols.
Exclusion
- Multiorgan transplants (liver-intestine, liver intestine with stomach and other organs)
- Documented non-compliance
- Donor: Age \>60, macrovesicular steatosis \> 30%, Hepatitis C and B infections defined as anti-HCV antibody positive, and anti-Hepatitis B surface antigen or Hepatitis B core antibody positive, malignancy, cold ischemia time \>16 hours
- Children of child-bearing age receive pregnancy testing at the time of transplantation. Pregnancy is a contraindication to liver transplantation and therefore to enrollment in this clinical trial.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01207141
Start Date
August 1 2006
End Date
May 1 2019
Last Update
March 7 2023
Active Locations (1)
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1
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213