TerminatedPhase 3

A Pilot Trial of Pediatric Liver Transplantation Without Steroids

Stopped: Study terminated due to withdrawal from market of Daclizumab

United Kingdom15 participantsStarted 2008-06

Plain-language summary

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.

Who can participate

Age range1 Day – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Primary endpoint: The development of histologically proven acute rejection. (within 12 months

Timeframe: 12m

Trial details

NCT IDNCT00694408

SponsorBirmingham Women's and Children's NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-08

View on ClinicalTrials.gov More Evidence of Liver Transplantation trials