Not Signed In -
Tacrolimus |
FK 506; Prograf |
Clinical Trial: Efficacy and Safety Assessment of Cyclosporine Microemulsion C2 Monitoring Versus Tacrolimus C0 Monitoring in De Novo Liver Transplant Recipients
This study is currently recruiting patients.
Verified by Novartis September 2005
|
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Liver transplant | Drug: Cyclosporine microemulsion and tacrolimus | Phase IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
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
Further Study Details:
Study start: December 2002
Eligibility
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: 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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00149994
Novartis 41 61 324 1111
Switzerland
Novartis, Basel, Switzerland; Recruiting
31 263 782 244
Study chairs or principal investigators
Novartis, Study Director, Novartis
More Information
Study ID Numbers: COLO400ANL07
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00149994
Health Authority: Netherlands: Independent Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00149994
Health Authority: Netherlands: Independent Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-13
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