Status:
COMPLETED
Sequential Therapy (FK506 + Monoclonal Anti-IL2R Antibodies + MMF) Versus FK506 With Steroids in Liver TX
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab), in comparison ...
Eligibility Criteria
Inclusion
- Patient is undergoing orthotopic liver allograft transplantation. This includes partial organ transplantation. Age of donor between 5 and 65 years
Exclusion
- Patient has previously received or is receiving an organ transplant (including liver re-transplantation)
- Recipient of an auxiliary graft or in which a bio-artificial liver has been used
- Patient is receiving a living related liver transplantation
- Patient is requiring steroids as well as chemotherapy prior to transplantation
- Patient having any previous history of neoplastic disease of any type (including leukaemia). However, patients with primary liver carcinoma can be included if they meet the following criteria:
- \> 3 nodes
- No node larger than 5 cm
- No metastases
- No vascular invasion
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00693524
Start Date
November 1 2002
End Date
March 1 2004
Last Update
August 26 2014
Active Locations (8)
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1
Bologna, Italy
2
Genova, Italy
3
Milan, Italy
4
Napoli, Italy