A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cyclosporine; Cyclosporins

Criteria

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.