Status:
COMPLETED
Tacrolimus and Daclizumab Versus Tacrolimus and Steroids in Liver Recipients Receiving Sub-optimal Grafts
Lead Sponsor:
Astellas Pharma Inc
Conditions:
LIVER TRANSPLANTATION
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare the safety and efficacy of two different tacrolimus based immunosuppressive regimens, one in combination with daclizumab, the other in combination with steroids,...
Detailed Description
Open, multicentre, 1:1 randomised, parallel group phase III study to compare safety and efficacy of tacrolimus (FK506) with monoclonal anti-IL2R antibodies (daclizumab) vs tacrolimus (FK506) with ster...
Eligibility Criteria
Inclusion
- Signed informed consent
- Adult patients scheduled to receive a liver transplant
- Donors older than 65 and/or has liver macrosteatosis \>15%
- Female patients of childbearing potential agree to maintain effective birth control during the study and must have negative pregnancy test at baseline
Exclusion
- Patient has previously received or is receiving an organ transplant other than liver, or a liver re-transplantation.
- Patient has significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer
- Patient is receiving an auxiliary graft or a bio-artificial liver has been used.
- Any pathology or medical condition that can interfere with this protocol study proposal
- Other exclusion applies
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00321074
Start Date
May 1 2005
End Date
October 1 2007
Last Update
August 26 2014
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Bergamo, Italy, 24122
2
Bologna, Italy, 40138
3
Milan, Italy, 20122
4
Milan, Italy, 20162