A randomised pilot trial of a steroid-free immunosuppressant regimen in paediatric liver transplantation

INTERVENTION: Arm 1: Patients randomised to steroid containing immunousppresion regimen post isolated liver transplant Arm 2: Patients randomised to steroid free immunosuppression regiment post isolated liver transplant Follow‐up length: 12 months Study entry: single randomisation only Added 22/10/2013: Blood tests Participants will have a little extra blood taken at the same time as routine blood tests. This extra blood will be tested to see how well the participant?s immune system is working to help prevent infections and also see how it is reacting to the new liver. Measuring tolerance Participants will have a planned liver biopsy one year after transplant. This biopsy will be tested to see if we can see any evidence of special cells that help tolerance to develop. Should participants require any extra unplanned biopsies for suspected rejection, these will also be tested for evidence of tolerance. The trial was prematurely discontinued as Roche withdrew daclizumab from the market, so it was decided to close the study rather than apply for a new authorisation from the MHRA to continue the study with an alternative monoclonal antibody. Recruitment closed September 2009. CONDITION: Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Hepatology ; Surgery ; Liver transplantation PRIMARY OUTCOME: Current primary outcome measures as of 22/10/2013:; The development of histologically proven acute rejection within 12 months.; ; Previous primary outcome measures:; Development of acute rejection; this can occur at any time post‐transplant SECONDARY OUTCOME: Current secondary outcome measures as of 22/10/2013:; 1. The development of steroid‐resistant acute rejection within 12 months; 2. The expression of tissue and circulating markers of immune tolerance in the first year post transplant; 3. The incidence of infection in the first year post transplant; ; Previous secondary outcome measures:; 1. Development of steroid‐resistant rejection; 2. Expression of tissue and circulating markers, analysed in batches. We intend to wait until all the study is closed and all the tests can be run at a single time. This may occur 24 months after the start of the study INCLUSION CRITERIA: 1. Children undergoing primary isolated hepatic transplantation 2. Aged less than or equal to 18 years, either sex 3. Ability to provide informed consent