CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 34 enrolled
Drug / intervention
Cyclosporine (Sandimmun® i.v.) +1 moredrug
Likely dose
Cyclosporine (Sandimmun® i.v.) 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00332462
NCT00332462Phase 4Completed
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A Multicenter, Open-label, Exploratory Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine During the First 7 Days Post Transplant Followed by Treatment With Cyclosporine Micro Emulsion in de Novo Liver Transplant Recipients

Novartis Pharmaceuticals·interventional·Posted Jun 1, 2006·Updated Mar 7, 2011

In Brief

A Phase 4 clinical trial evaluating Cyclosporine (Sandimmun® i.v.) and Cyclosporine (Sandimmun® Optoral) for Liver Transplantation. Completed, enrolled 34 participants across 1 site.

Detailed Summary

The aim of this exploratory study is to evaluate the rejection rate in patients treated with cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h monitoring. In addition, this study will assess the safety of this treatment regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Transplantation
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 1, 2006
Enrollment StartMay 1, 2006
Primary CompletionApr 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 20.1 years ago

Interventions

Cyclosporine (Sandimmun® i.v.)drug

Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.

Cyclosporine (Sandimmun® Optoral)drug

Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.