Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06774144 | Rezafungin Prophylaxis in Liver Transplant | PHASE3 | ENROLLING BY_INVITATION | 385 | — | — | Oct 15, 2025 | Dec 1, 2028 | Oct 20, 2025 | 1 | United States |
Incidence of proven and probable IFIs within 90 days post-transplant
Incidence of breakthrough IFI while on specific antifungal prophylaxis
| Arm | Type | Description |
|---|---|---|
| Prospective Intervention Cohort | EXPERIMENTAL | Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV once weekly for a total duration of 4 weeks |
| Prospective Control Cohort | ACTIVE_COMPARATOR | Patients who receive fluconazole/voriconazole or no antifungal prophylaxis as part of UPMC's risk-based antifungal prophylaxis standard of care after liver transplant |
| Historical Control Group | ACTIVE_COMPARATOR | Patients at risk for IFI who received fluconazole/voriconazole for antifungal prophylaxis after liver transplant in the two years preceding the study |
| Name | Type | Description |
|---|---|---|
| Rezafungin | DRUG | Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV weekly for 4 weeks. |
| Standard of care antifungal prophylaxis | DRUG | UPMC uses a tiered approach to antifungal prophylaxis, based on risk factors for IFI. Fluconazole is used for recipients with risk factors for yeast infections: choledochojejunostomy, prolonged transplant time, receipt of \>40 units of blood products within 24 hours of transplant, and Candida colonization or infection within 3 months prior to transplant. Voriconazole is used for recipients with risk factors for mould infections: re-transplantation, renal failure requiring renal replacement therapy, fulminant hepatic failure as indication for transplant, intra-abdominal/thoracic re-exploration within the first month after transplant. No prophylaxis is given if there are no risk factors for yeast or mould infections. |
Inclusion Criteria: * Liver transplant recipient * 18 years of age or older * ≥1 risk factor(s) for IFI: living donor transplant, retransplantation, complicated operations (based on duration of transplant and number of blood products required in the peri-transplant period), choledochojejunostomy an...