A Pilot Trial of Pediatric Liver Transplantation Without Steroids

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Pilot Trial of a Steroid-free Immunosuppressant Regimen in Pediatric Liver Transplantation

Conditions
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Evidence of Liver Transplantation

Intervention / Treatment
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* Drug: methyl prednisolone, hydrocortisone, prednisolone
* Other: No steroids


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid immunosuppressive regimen<br>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<br>* Will be specific dependant on weight of patients<br>* Other names: Methylprednisolone;Hydrocortisone;Prednisolone;|
| Active Comparator: Steroid free immunosuppressive regimen<br>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<br>* Children undergoing primary liver transplant will receive monoclonal antibodies and tacrolimus as per protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint: The development of histologically proven acute rejection. (within 12 months |  | 12m | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End stage liver disease, Paediatric liver transplantation, Steroid free immunosuppression