A Pilot Trial of Pediatric Liver Transplantation Without Steroids

January 19, 2017 updated by: Birmingham Women's and Children's NHS Foundation Trust

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B4 6NH
        • Birmingham Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 12m
12m

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Birmingham Women's and Children's NHS Foundation Trust

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Patrick McKiernan, MRCP FRCPCH, Birmingham Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 6, 2008

First Submitted That Met QC Criteria

June 9, 2008

First Posted (Estimate)

June 10, 2008

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFPT/OL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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