Evidence of Liver Transplantation
Conditions
Keywords
End stage liver disease, Paediatric liver transplantation, Steroid free immunosuppression
Brief summary
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.
Detailed description
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.
Interventions
DRUGmethyl prednisolone, hydrocortisone, prednisolone
Will be specific dependant on weight of patients
OTHERNo steroids
Children undergoing primary liver transplant will receive monoclonal antibodies and tacrolimus as per protocol
Sponsors
Roche Pharma AG
Birmingham Women's and Children's NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children undergoing primary isolated hepatic transplantation. * Age \<=18 years * Ability to provide informed consent
Exclusion criteria
* Children undergoing retransplantation. * Transplantation for Intestinal failure associated liver disease. * Multi-organ transplantation. * Transplantation for autoimmune liver disease. * Transplantation for extra hepatic malignancy. * Pre-existing need for oral steroids, or high dose inhaled steroids sufficient to require a steroid warning card.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: The development of histologically proven acute rejection. (within 12 months | 12m |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 12m |
Countries
United Kingdom
Outcome results
None listed