A Trial to Assess Campath-1H and Tacrolimus Followed by Immunosuppression Withdrawal in Liver Transplantation
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|ClinicalTrials.gov Identifier: NCT00166556|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : May 23, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Transplantation, Liver||Drug: Campath-1H and Tacrolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thistlethwaite Protocol # ITN025ST - Immunosuppression With Campath-1H and Tacrolimus in Liver Transplantation|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
- To evaluate the safety and efficacy of an immunosuppression regimen comprising Campath-1H induction followed by maintenance therapy with tacrolimus in allowing liver allograft survival
- Assess the safety of withdrawing tacrolimus after Campath-1H induced immuno-depletion and subsequent immune reconstitution
- Gather additional safety information about the combination of Campath-1H and tacrolimus in liver allograft recipients
- Define profiles of immunologic and genetic features present prior to or during tapering of immunosuppression that distinguish tolerant and non tolerant allograft recipients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00166556
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Russell H. Wiesner, M.D.||Mayo Clinic|