Objective: The overall objective is to investigate whether a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following pediatric liver transplantation and whether it promotes tolerance.
3.2 Research question Is it possible to avoid the use of corticosteroids in pediatric liver transplantation? 3.3 Trial objectives This will be a pilot study to i) investigate to what degree a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following pediatric liver transplantation ii) investigate the effect of a steroid free immunosuppressive regimen on lymphocyte function and donor-specific immune responsiveness following pediatric liver transplantation iii) investigate the effect of a steroid free immunosuppressive regimen on expression of tissue markers of tolerance following pediatric liver transplantation It is hoped that this pilot study will be used to develop a definitive multicentre study of a steroid free regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Will be specific dependant on weight of patients
Children undergoing primary liver transplant will receive monoclonal antibodies and tacrolimus as per protocol
Birmingham Children's Hospital
Birmingham, West Midlands, United Kingdom
Primary endpoint: The development of histologically proven acute rejection. (within 12 months
Time frame: 12m
The development of steroid resistant acute rejection 12 months. The expression of tissue and circulating markers of immune tolerance in first year post transplant The incidence of infection in the first year post transplant
Time frame: 12m
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.