Try our beta test site

A Pilot Trial of Pediatric Liver Transplantation Without Steroids

This study has been terminated.
(Study terminated due to withdrawal from market of Daclizumab)
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Birmingham Children's Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00694408
First received: June 6, 2008
Last updated: January 19, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention Phase
Evidence of Liver Transplantation
Drug: methyl prednisolone, hydrocortisone, prednisolone
Other: No steroids
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Randomized Pilot Trial of a Steroid-free Immunosuppressant Regimen in Pediatric Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Birmingham Children's Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Primary endpoint: The development of histologically proven acute rejection. (within 12 months [ Time Frame: 12m ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: June 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694408

Locations
United Kingdom
Birmingham Children's Hospital
Birmingham, West Midlands, United Kingdom, B4 6NH
Sponsors and Collaborators
Birmingham Children's Hospital NHS Foundation Trust
Roche Pharma AG
Investigators
Principal Investigator: Patrick McKiernan, MRCP FRCPCH Birmingham Children's Hospital
  More Information

Publications:

Responsible Party: Birmingham Children's Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00694408     History of Changes
Other Study ID Numbers: SFPT/OL 
Study First Received: June 6, 2008
Last Updated: January 19, 2017

Keywords provided by Birmingham Children's Hospital NHS Foundation Trust:
End stage liver disease
Paediatric liver transplantation
Steroid free immunosuppression

Additional relevant MeSH terms:
Liver Extracts
Prednisolone acetate
Methylprednisolone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Hydrocortisone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Hematinics
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 28, 2017