Phase 4
Completed N=34
A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients
Source: ClinicalTrials.gov NCT00332462 ↗Enrolled (actual)
34
Serious AEs
50.8%
Results posted
Jan 2011
Primary outcomePrimary: Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation — 8; 26 Participants
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.
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 | — |
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.
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. Informational only — not medical advice.