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A Pilot Trial of Pediatric Liver Transplantation Without Steroids

NCT00694408 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-01-20

No results posted yet for this study

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.

Conditions

  • Evidence of Liver Transplantation

Interventions

DRUG

methyl prednisolone, hydrocortisone, prednisolone

Will be specific dependant on weight of patients

OTHER

No steroids

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

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Birmingham Women's and Children's NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Patrick McKiernan, MRCP FRCPCH · Birmingham Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00694408 on ClinicalTrials.gov