A Pilot Trial of Pediatric Liver Transplantation Without Steroids

Phase 3

Terminated

• Conditions: Evidence of Liver Transplantation
• Interventions: Drug: methyl prednisolone, hydrocortisone, prednisolone; Other: No steroids

• Registration Number: NCT00694408
• Lead Sponsor: Birmingham Women's and Children's NHS Foundation Trust

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-10
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid immunosuppressive regimen	methyl prednisolone, hydrocortisone, prednisolone	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
Steroid free immunosuppressive regimen	No steroids	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

Primary Outcome Measures

Name	Time	Method
Primary endpoint: The development of histologically proven acute rejection. (within 12 months	12m

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Birmingham Children's Hospital; 🇬🇧 Birmingham, West Midlands, United Kingdom