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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Transplantation

Intervention: Cyclosporine (Sandimmun® i.v.) (Drug); Cyclosporine (Sandimmun® Optoral) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation

Secondary outcome: Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

Novartis Investigational Site, Various Cities, Germany
Additional Information

Starting date: May 2006
Last updated: March 1, 2011

Page last updated: August 23, 2015

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