A Trial to Assess Campath-1H and Tacrolimus Followed by Immunosuppression Withdrawal in Liver Transplantation
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
This is a prospective, multicenter open-label single arm trial in which recipients of liver
allograft will receive uniform immunosuppressive induction and maintenance regimens.
Participants with end stage liver disease who meets the entry criteria will be consented and
enrolled.
Participants receive Campath-1H and maintenance immunosuppression with tacrolimus therapy.
After one year of tacrolimus therapy, an assessment of the immunologic status including blood
gene expression and geno-race studies will be performed which will include studies on the
liver graft biopsy. At this time, patients will be selected to undergo immunosuppressive
withdrawal. This will be made on an individual basis with definitive inclusion and exclusion
criteria.
The objectives of the study are to evaluate the safety and efficacy of immunosuppressive
regimens comprising Campath-1H induction followed by maintenance immunosuppressive therapy
with tacrolimus on allograft survival. However, secondary objectives will be to assess
withdrawing tacrolimus after Campath-1H induction in an immune depletion and subsequent
immune reconstitution. This study will evaluate whether a combination of anti-rejection
medications (Campath-1H and tacrolimus) can prevent rejection and allow the body to develop
tolerance to the transplanted liver.
Phase:
Phase 2
Details
Lead Sponsor:
Mayo Clinic
Collaborators:
Immune Tolerance Network (ITN) University of Chicago