Extension Of The Pediatric Liver Transplantation Trial Is Planned For Immunosuppression Withdrawn Participants Reaching The End Of The Two-Year Observation Period

November 9, 2011

The pediatric liver transplantation trial (Feng) of Immunosuppression Withdrawal for Pediatric Living-donor Liver Transplant Recipients recently began an extension phase of the trial.

The open-label, single-arm trial led by protocol chair Dr. Sandy Feng, was conducted at three clinical research sites, in which 20 pediatric recipients of parental living-donor allografts underwent gradual withdrawal of immunosuppression with the goal of complete withdrawal. Twelve of the 20 enrolled pediatric participants have successfully tapered from immunosuppression and have been followed for up to two years post-therapy.

Participants in the original trial consisted of living-donor liver transplantation recipients who were under the age of 18 years at the time of transplantation and at least four years since transplantation to be eligible for the trial. Those 12 participants that have successfully completed immunosuppression withdrawal, as defined as those who remain off immunosuppression for at least one year, and have reached the end of the originally designed two-year observation period, may now elect to continue study participation in the extension phase for another four years.

Following these tolerant patients for an additional four years will hopefully strengthen our understanding about the pediatric liver transplant patient’s unique experience of remaining without immunosuppression medication for an extended period of time post-transplantation.

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