Trials / Completed
CompletedNCT01058174
Liver Transplant European Study Into the Prevention of Fungal Infection
Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 350 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prevention of invasive fungal infection in high risk patients following liver transplant.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | micafungin | intravenous infusion |
| DRUG | fluconazole | intravenous infusion |
| DRUG | liposomal amphotericin B | intravenous infusion |
| DRUG | caspofungin | intravenous infusion |
Timeline
- Start date
- 2009-12-15
- Primary completion
- 2012-05-03
- Completion
- 2012-05-03
- First posted
- 2010-01-28
- Last updated
- 2024-11-18
Locations
36 sites across 14 countries: Austria, Belgium, France, Germany, Hungary, Ireland, Italy, Portugal, Romania, Russia, Saudi Arabia, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01058174. Inclusion in this directory is not an endorsement.