A Pilot Trial of Pediatric Liver Transplantation Without Steroids

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Birmingham Children's Hospital NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Birmingham Children's Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00694408
First received: June 6, 2008
Last updated: June 9, 2008
Last verified: June 2008
  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
Transplantation
Drug: methyl prednisolone, hydrocortisone, prednisolone
Other: No steroids
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Steroid containing immunosuppression regimen post paediatric liver transplant
Drug: methyl prednisolone, hydrocortisone, prednisolone
Will be specific dependant on weight of patients
Other Name: Methylprednisolone;Hydrocortisone;Prednisolone
2
Steroid free immunosuppression regimen following paediatric liver transplantation
Other: No steroids
Other Name: No steroids

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
Genders Eligible for Study:   Both
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

Contacts
Contact: Patrick J McKiernan, MRCP FRCPCH 44-12-1333-8262 pat.mckiernan@bch.nhs.uk
Contact: Carla McKiernan, BSc 44-12-1333-8257 carla.lloyd@bch.nhs.uk

Locations
United Kingdom
Birmingham Children's Hospital Not yet recruiting
Birmingham, West Midlands, United Kingdom, B4 6NH
Principal Investigator: Patrick McKiernan, MRCP FRCPCH         
Sponsors and Collaborators
Birmingham Children's Hospital NHS Foundation Trust
Hoffmann-La Roche
Investigators
Principal Investigator: Patrick McKiernan, MRCP FRCPCH Birmingham Children's Hospital
  More Information

Publications:

Responsible Party: Mrs Carole Cummins, Birmingham Children's Hospital
ClinicalTrials.gov Identifier: NCT00694408     History of Changes
Other Study ID Numbers: SFPT/OL
Study First Received: June 6, 2008
Last Updated: June 9, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Methylprednisolone acetate
Prednisolone acetate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Hydrocortisone
Prednisolone hemisuccinate
Prednisolone phosphate
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 18, 2014