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Vfend- voriconazole

Phase 3

Antifungal Prophylaxis of Invasive Fungal Infections | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Nov 20, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment489

FDA Designations

No designations recorded

Clinical trial landscape

Vfend- voriconazole · 1 trial · 1 indication

Phase 3 1
NCT00289991Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)Antifungal Prophylaxis of Invasive Fungal Infections
COMPLETED489 Analytics
PHASE3COMPLETED
Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
Antifungal Prophylaxis of Invasive Fungal InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Success at Day 180: Percent of Responders (Randomization Strata)
Day 180 (Visit 9)

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).

Secondary Endpoints

Success at Day 100: Percent of Responders (Randomization Strata)
Day 100 (Visit 7)
Time to Breakthrough Invasive Fungal Infection (IFI)
Day 1 up to Day 180 (Visit 9)
Percent of Subjects With Occurrence of Breakthrough IFI
Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
ItraconazoleACTIVE_COMPARATOR -
VoriconazoleEXPERIMENTAL -

Interventions

NameTypeDescription
ItraconazoleDRUGProphylaxis
Vfend - voriconazoleDRUGProphylaxis
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites49

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...

Countries:CanadaCzechiaEgyptFranceGreeceJordanPortugalRussiaSpainSwitzerlandTurkey (Türkiye)United Kingdom
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Frequently asked questions about Vfend- voriconazole

What is Vfend (voriconazole) used for?

Vfend (voriconazole) is used for antifungal prophylaxis of invasive fungal infections, specifically in patients undergoing allogeneic hematopoietic stem cell transplants. It is a small molecule developed by Pfizer, Inc. for the Infectious Disease therapeutic area.

Who makes Vfend (voriconazole)?

Vfend (voriconazole) is developed by Pfizer, Inc., which trades under the ticker PFE. The drug is a small molecule intended for antifungal prophylaxis of invasive fungal infections.

What phase is Vfend (voriconazole) in?

Vfend (voriconazole) is in Phase 3 clinical development. It is an investigational drug for antifungal prophylaxis of invasive fungal infections and is not approved for this use based on the available data.

What clinical trials is Vfend (voriconazole) in?

Vfend (voriconazole) has one completed Phase 3 trial, NCT00289991, which enrolled 489 participants. The trial compared voriconazole to itraconazole for primary prophylaxis of invasive fungal infection in subjects with allogeneic hematopoietic stem cell transplants.

Is Vfend (voriconazole) the same as voriconazole?

Yes, Vfend is the brand name for voriconazole. The drug is referred to as Vfend (voriconazole) in clinical development, and the active ingredient is voriconazole.