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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00289991 | Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT) | PHASE3 | COMPLETED | 489 | — | — | Mar 1, 2006 | Feb 1, 2009 | Nov 20, 2015 | 49 | Canada, Czechia +10 |
Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).
| Arm | Type | Description |
|---|---|---|
| Itraconazole | ACTIVE_COMPARATOR | - |
| Voriconazole | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Itraconazole | DRUG | Prophylaxis |
| Vfend - voriconazole | DRUG | Prophylaxis |
Inclusion Criteria: * Allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failed lymphoma therapy or transformation of CML * Male and Female over 12 years or greater Exclusion Criteria: * Possible, probable or proven IFI at study entry or at any time in 6 months prior to stu...