Phase 4 N=34 Treatment

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

Liver Transplantation

Bottom Line

View on ClinicalTrials.gov: NCT00332462 ↗

Enrolled (actual)

Serious AEs

50.8%

Results posted

Jan 2011

Primary outcome: Primary: Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation — 8; 26 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Cyclosporine (Sandimmun® i.v.) (Drug); Cyclosporine (Sandimmun® Optoral) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation	8; 26	—
SECONDARY Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation	NA; 10; NA; 24; 7; 8	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00332462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.