A Phase 3 interventional study of methyl prednisolone, hydrocortisone, prednisolone and No steroids in Evidence of Liver Transplantation, sponsored by Birmingham Women's and Children's NHS Foundation Trust. Terminated at 1 site in United Kingdom. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2017-01-20.
Sponsored by Birmingham Women's and Children's NHS Foundation Trust · Phase 3, Interventional, and Treatment
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.
Birmingham Women's and Children's NHS Foundation Trust is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Freedom from rejection and safety in children undergoing paediatric liver transplant using steroid containing immunosuppression regimen post transplant. This group of patients will receive steroids in conjunction with other prescribed immunosuppressive agents. Intervention is use of methyl prednisolone, hydrocortisone, prednisolone as routine post transplant management
Drug: methyl prednisolone, hydrocortisone, prednisolone
Freedom from rejection and safety in children undergoing paediatric liver transplant using steroid free immunosuppression regimen post transplant. The patients in this arm will receive immunosuppression but not steroids to compare with those treated with steroids to measure differences in rejection and safety of a steroid free immunosuppressive regimen. Intervention is omission of methyl prednisolone, hydrocortisone, prednisolone as routine post transplant management. No steroids will be used routinely in this arm
Other: No steroids
Will be specific dependant on weight of patients
Also known as: Methylprednisolone;Hydrocortisone;Prednisolone
Children undergoing primary liver transplant will receive monoclonal antibodies and tacrolimus as per protocol
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 study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Birmingham Women's and Children's NHS Foundation Trust