NCT00694408

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

3.2 years

First QC Date

June 6, 2008

Last Update Submit

January 19, 2017

Conditions

Evidence of Liver Transplantation

Keywords

End stage liver diseasePaediatric liver transplantationSteroid free immunosuppression

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint: The development of histologically proven acute rejection. (within 12 months

    12m

Secondary Outcomes (1)

  • 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

Study Arms (2)

Steroid immunosuppressive regimen

ACTIVE COMPARATOR

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

Steroid free immunosuppressive regimen

ACTIVE COMPARATOR

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

Interventions

methyl prednisolone, hydrocortisone, prednisoloneDRUG

Will be specific dependant on weight of patients

Also known as: Methylprednisolone;Hydrocortisone;Prednisolone
Steroid immunosuppressive regimen
No steroidsOTHER

Children undergoing primary liver transplant will receive monoclonal antibodies and tacrolimus as per protocol

Steroid free immunosuppressive regimen

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children undergoing primary isolated hepatic transplantation.
  • Age \<=18 years
  • Ability to provide informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birmingham Children's Hospital

Birmingham, West Midlands, B4 6NH, United Kingdom

Location

Related Publications (10)

  • Sarwal MM, Vidhun JR, Alexander SR, Satterwhite T, Millan M, Salvatierra O Jr. Continued superior outcomes with modification and lengthened follow-up of a steroid-avoidance pilot with extended daclizumab induction in pediatric renal transplantation. Transplantation. 2003 Nov 15;76(9):1331-9. doi: 10.1097/01.TP.0000092950.54184.67.

    PMID: 14627912BACKGROUND

  • Vidhun JR, Sarwal MM. Corticosteroid avoidance in pediatric renal transplantation. Pediatr Nephrol. 2005 Mar;20(3):418-26. doi: 10.1007/s00467-004-1786-4. Epub 2005 Feb 3.

    PMID: 15690189BACKGROUND

  • Leonard H, Hornung T, Parry G, Dark JH. Pediatric cardiac transplant: results using a steroid-free maintenance regimen. Pediatr Transplant. 2003 Feb;7(1):59-63. doi: 10.1034/j.1399-3046.2003.00014.x.

    PMID: 12581330BACKGROUND

  • Walsh PT, Taylor DK, Turka LA. Tregs and transplantation tolerance. J Clin Invest. 2004 Nov;114(10):1398-403. doi: 10.1172/JCI23238.

    PMID: 15545987BACKGROUND

  • Yoshizawa A, Ito A, Li Y, Koshiba T, Sakaguchi S, Wood KJ, Tanaka K. The roles of CD25+CD4+ regulatory T cells in operational tolerance after living donor liver transplantation. Transplant Proc. 2005 Jan-Feb;37(1):37-9. doi: 10.1016/j.transproceed.2004.12.259.

    PMID: 15808539BACKGROUND

  • Hathaway M, Adams DH. Demonstration that donor-specific nonresponsiveness in human liver allograft recipients is both rare and transient. Transplantation. 2004 Apr 27;77(8):1246-52. doi: 10.1097/01.tp.0000121136.84965.35.

    PMID: 15114093BACKGROUND

  • Arora-Gupta N, Davies P, McKiernan P, Kelly DA. The effect of long-term calcineurin inhibitor therapy on renal function in children after liver transplantation. Pediatr Transplant. 2004 Apr;8(2):145-50. doi: 10.1046/j.1399-3046.2003.00132.x.

    PMID: 15049794BACKGROUND

  • Evans HM, McKiernan PJ, Kelly DA. Mycophenolate mofetil for renal dysfunction after pediatric liver transplantation. Transplantation. 2005 Jun 15;79(11):1575-80. doi: 10.1097/01.tp.0000163504.29054.3f.

    PMID: 15940048BACKGROUND

  • Kelly D, Jara P, Rodeck B, Lykavieris P, Burdelski M, Becker M, Gridelli B, Boillot O, Manzanares J, Reding R. Tacrolimus and steroids versus ciclosporin microemulsion, steroids, and azathioprine in children undergoing liver transplantation: randomised European multicentre trial. Lancet. 2004 Sep 18-24;364(9439):1054-61. doi: 10.1016/S0140-6736(04)17060-8.

    PMID: 15380964BACKGROUND

  • Reding R, Gras J, Sokal E, Otte JB, Davies HF. Steroid-free liver transplantation in children. Lancet. 2003 Dec 20;362(9401):2068-70. doi: 10.1016/S0140-6736(03)15104-5.

    PMID: 14697809BACKGROUND

MeSH Terms

Conditions

End Stage Liver Disease

Interventions

HydrocortisonePrednisolone

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsPregnadienetriolsPregnadienes

Study Officials

  • Patrick McKiernan, MRCP FRCPCH

    Birmingham Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2008

First Posted

June 10, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 20, 2017

Record last verified: 2017-01

Locations

GB(1)