A randomised pilot trial of a steroid-free immunosuppressant regimen in paediatric liver transplantation - A pilot trial of paediatric liver transplantation without steroids
Phase 1
- Conditions
- Post isolated liver transplant complications
- Registration Number
- EUCTR2007-004822-26-GB
- Lead Sponsor
- Birmingham Children's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Children undergoing primary isolated hepatic transplantation.
Age <=18 years
Ability to provide informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method