Cyclosporine Microemulsion C2 Monitoring Versus Tacrolimus C0 Monitoring in de Novo Liver Transplant Recipients
Information source: Novartis
Information obtained from ClinicalTrials.gov on August 03, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Transplant
Intervention: Cyclosporine microemulsion and tacrolimus (Drug)
Phase: Phase 4
Status: No longer recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis
Summary
The purpose of this study is to determine whether cyclosporine microemulsion monitored by C2 will show equivalent or superior efficacy compared to tacrolimus monitored by C0. In addition this study will assess the safety and tolerability of a cyclosporine microemulsion regimen based on C2 monitoring in comparison to the standard tacrolimus regimen
Clinical Details
Official title:
DELTA Study Dutch Evaluation in Liver Transplantation To Assess the Efficacy of Cyclosporine Microemulsion With C2 Monitoring Versus Tacrolimus With Trough Monitoring in de Novo Liver Transplant Recipients
Study design: Interventional, Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- primary liver transplant
- age between 18 and 75
- expected to be able to receive the first oral dose of CNI within the first 24 hours post-transplantation (Tx)
Exclusion Criteria:
- Multi-organ transplant
- Urine production is <200 ml within 12 hours after reperfusion of the graft
- Severe coexisting disease present which could affect the study objectives
Other protocol-defined exclusion criteria applied
Locations and Contacts
Novartis, Basel, Switzerland
Additional Information
Starting date:
December 2002
Last updated: January 25, 2007
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