Status:
COMPLETED
Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Liver Transplant
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy com...
Eligibility Criteria
Inclusion
- About to undergo a primary liver transplant (including living donor, non-heart beating donor and split liver).
- Age between 18 and 75 years.
- Expected to be able to receive the first oral dose of CNI within the first 24 hours post-transplantation (Tx)
Exclusion
- This is a multi-organ transplant or if the patient has previously been transplanted with any other organ.
- Urine production is \<200 ml within 12 hours after reperfusion of the graft
- Severe coexisting disease is present or if any unstable medical condition is present which could affect the study objectives.
- Other protocol-defined exclusion criteria applied
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00149994
Start Date
December 1 2002
End Date
December 1 2007
Last Update
April 12 2011
Active Locations (1)
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1
Novartis
Basel, Switzerland