A Pilot Trial of Pediatric Liver Transplantation Without Steroids
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00694408 |
Recruitment Status
:
Terminated
(Study terminated due to withdrawal from market of Daclizumab)
First Posted
: June 10, 2008
Last Update Posted
: January 20, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Evidence of Liver Transplantation | Drug: methyl prednisolone, hydrocortisone, prednisolone Other: No steroids | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Pilot Trial of a Steroid-free Immunosuppressant Regimen in Pediatric Liver Transplantation |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2011 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | up to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694408
United Kingdom | |
Birmingham Children's Hospital | |
Birmingham, West Midlands, United Kingdom, B4 6NH |
Principal Investigator: | Patrick McKiernan, MRCP FRCPCH | Birmingham Children's Hospital |
Publications:
Responsible Party: | Birmingham Women's and Children's NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT00694408 History of Changes |
Other Study ID Numbers: |
SFPT/OL |
First Posted: | June 10, 2008 Key Record Dates |
Last Update Posted: | January 20, 2017 |
Last Verified: | January 2017 |
Keywords provided by Birmingham Women's and Children's 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 Hydrocortisone acetate Cortisol succinate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Hydrocortisone Prednisolone hemisuccinate Prednisolone phosphate Immunosuppressive Agents Hematinics |
Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Immunologic Factors |