A Pilot Trial of Pediatric Liver Transplantation Without Steroids

Birmingham Women's and Children's NHS Foundation Trust

Status and phase: Terminated; Phase 3

Conditions: Evidence of Liver Transplantation

Treatments: Drug: methyl prednisolone, hydrocortisone, prednisolone; Other: No steroids

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00694408

SFPT/OL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Steroid immunosuppressive regimen

Active Comparator group

Description:

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

Treatment:

Drug: methyl prednisolone, hydrocortisone, prednisolone

Steroid free immunosuppressive regimen

Active Comparator group

Description:

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

Treatment:

Other: No steroids