Sequential Therapy (FK506 + Monoclonal Anti-IL2R Antibodies + MMF) Versus FK506 With Steroids in Liver TX
NCT00693524 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94
Last updated 2014-08-26
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 with a standard steroid + tacrolimus double drug regimen
Conditions
- Liver Transplantation
Interventions
- DRUG
-
oral
- DRUG
-
Anti-IL2R AB
i.v.
- DRUG
-
Mycophenolate mofetil
oral
- DRUG
-
oral
Sponsors & Collaborators
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Central Contact · Astellas Pharma Europe B.V.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-11-30
- Primary Completion
- 2004-03-31
- Completion
- 2004-03-31
Countries
- Italy
Study Locations
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