Status:
COMPLETED
Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation.
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.
Detailed Description
This prospective randomised trial which combines MMF with tacrolimus and so avoids steroids in immunosuppressive maintenance could demonstrate alternatives to current immunosuppressive regimens. There...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older who will undergo primary orthotopic liver or split liver allograft transplantation are eligible for the study. Patients receiving a liver transplant from cadaveric heart-beating donor with compatible AB0 blood type can be included.
Exclusion
- Recipient of an auxiliary graft
- Patient is requiring initial sequential or parallel therapy with other immunosuppressive antibody preparation(s).
- Patient is requiring ongoing dosing with corticosteroids.
- Patient is exhibiting symptoms of, or is having any previous history of neoplastic disease
- Patient or donor is known to be HIV positive.
- Patient is allergic or intolerant to study medication
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
627 Patients enrolled
Trial Details
Trial ID
NCT00295594
Start Date
March 1 2005
End Date
June 1 2007
Last Update
August 26 2014
Active Locations (41)
Enter a location and click search to find clinical trials sorted by distance.
1
Ghent, Belgium, 9000
2
Leuven, Belgium, 3000
3
Liège, Belgium
4
Copenhagen, Denmark