At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 489 enrolled
Drug / intervention
Itraconazole +1 moredrug
Likely dose
Not stated in record
Key inclusion· 2
- ✓Undergoing allogeneic HSCT for acute leukemia (AML, ALL), myelodysplastic syndrome, failed lymphoma therapy, or CML transformation
- ✓Age over 12 years
Key exclusion· 3
- ✕Possible, probable, or proven IFI at study entry or within 6 months prior, per consensus criteria
- ✕Prior history of zygomycosis
- ✕Anticipated survival less than one month
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective, Open-Label, Comparative, Multi-Center Study Of Voriconazole Compared To Itraconazole For The Primary Prophylaxis Of Invasive Fungal Infection (IFI) With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
In Brief
A Phase 3 clinical trial evaluating Itraconazole and Vfend - voriconazole for Antifungal Prophylaxis of Invasive Fungal Infections. Completed, enrolled 489 participants across 49 sites in 12 countries.
Detailed Summary
Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Czechia, Egypt, France, Greece, Jordan, Portugal, Russia, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2006
Enrollment StartMar 2006
Primary CompletionFeb 2009
TodayJul 2026
First PostedFeb 10, 2006
Enrollment StartMar 1, 2006
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.4 years ago
Interventions
Itraconazoledrug
Prophylaxis
Vfend - voriconazoledrug
Prophylaxis