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...
Date First Received: May 30, 2006
Last Updated: July 3, 2008
Verified by: Novartis, July 2008
Clinical Trial Phase: Phase 4 | Start Date: May 2006
Overall Status: Recruiting
Estimated Enrollment: 50
Brief Summary
Official Title: “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”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: cyclosporine
- Drug: cyclosporine
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Active Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Incidence of biopsy proven acute rejection during the first 3 months post de novo liver transplantation.
Secondary Measures
- Incidence, safety and tolerability of cyclosporine i.v. during 6 months post de novo liver transplantation
Criteria for Participation in this Clinical Trial
Inclusion Criteria
- About to undergo a primary liver transplant (including living donor, split liver).
- Expected to be capable of study participation for full 6 months post-transplantation.
- Allograft biopsies will be possible.
Exclusion Criteria
- The surgery is a multi-organ transplant.
- The patient has previously been transplanted with any other organ.
- The graft derives from a non-heart beating donor.
- Other protocol-defined inclusion/exclusion criteria may apply.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Study Director Novartis
Overall Contact: novartis 41613241111
Additional Information
Information obtained from ClinicalTrials.gov on October 06, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00332462
Study ID Number: COLO400ADE01
ClinicalTrials.gov Identifier: NCT00332462
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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