The use of Myfortic in paediatric patients after liver transplantatio
- Conditions
- iver transplantation
- Registration Number
- EUCTR2005-001830-34-GB
- Lead Sponsor
- King's College Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 4
Group 1: high risk for kidney dysfunction or pre-existing kidney dysfunction (GFR <80 ml/min/1.73m2). This inlcudes but is not limited to childen transplanted for hepatoblastoma, Alagilles syndrome, cystic fibrosis, alpha-1-antitrypsin deficiency, hyperoxuluria. The child is able to swallow tablets whole
Group 2: The child is experiencing gastrointestinal side effects of MMF requiring it to be reduced. The child is able to swallow tablets whole.
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
Parental consent and child assent has not been ascertained, pregnancy (all sexually active girls >12 years will have a pregnancy test prior to starting the study drug); hypersensitivity to mycophenolate
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