Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166556
Status:
COMPLETED
Last Update Posted:
2011-05-23
First Post:
2005-09-12
Brief Title:
A Trial to Assess Campath-1H and Tacrolimus Followed by Immunosuppression Withdrawal in Liver Transplantation
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Thistlethwaite Protocol ITN025ST - Immunosuppression With Campath-1H and Tacrolimus in Liver Transplantation
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None