A Phase 3 interventional study of micafungin and fluconazole in Liver Transplantation and Mycoses, sponsored by Astellas Pharma Inc. Completed at 36 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Astellas Pharma Inc · Phase 3, Interventional, and Prevention
Prevention of invasive fungal infection in high risk patients following liver transplant.
After receiving liver transplant, subjects will be randomized to one of the two treatment arms.
Study drugs will be administered for a period of 21 days, or until hospital discharge, whichever occurs first.
Additionally, mortality data will be collected at the Long-term Follow-up.
539 studies on the registry are indexed under Mycoses; 55 are open to participants now.
This study's enrollment of 350 is above the median of 46 across 358 interventional studies indexed under Mycoses.
Browse Mycoses studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients at 'high risk' of invasive fungal infection due to the presence of at least one of the following risk factors:
Exclusion Criteria:
intravenous infusion
Drug: micafungin
intravenous infusion
Drug: fluconazole · Drug: liposomal amphotericin B · Drug: caspofungin
intravenous infusion
Also known as: Mycamine
intravenous infusion
Also known as: Diflucan
intravenous infusion
Also known as: AmBisome
intravenous infusion
Also known as: Cancidas
'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB).
Time frame: up to 21 days
Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB
Time frame: 3 months
Absence of 'proven' or 'probable' IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator
Time frame: up to 21 days & 3 months
Time to 'proven' or 'probable' IFD
Time frame: up to 3 months
Fungal free survival at the End of Study and at the end of Long-term Follow-up
Time frame: 3 months & 6 months
Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline
Time frame: up to 21 days
Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc