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Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)

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NCT00289991

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 1M9 Canada
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Antifungal Prophylaxis of Invasive Fungal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Possible, probable or proven IFI at study entry or at any time in 6 months prior to
study entry, defined according to the 'consensus criteria' (Ascioglu et al 2002)

- Previous history of zygomycosis

- Anticipated survival less than one month

NCT00289991
Pfizer
Completed
Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)

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Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Antifungal Prophylaxis of Invasive Fungal Infections
  • Drug: Itraconazole
    Prophylaxis
  • Drug: Vfend - voriconazole
    Prophylaxis
    Other Name: Vfend
  • Active Comparator: Itraconazole
    Intervention: Drug: Itraconazole
  • Experimental: Voriconazole
    Intervention: Drug: Vfend - voriconazole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
489
February 2009
February 2009   (Final data collection date for primary outcome measure)

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 study entry, defined according to the 'consensus criteria' (Ascioglu et al 2002)
  • Previous history of zygomycosis
  • Anticipated survival less than one month
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   Egypt,   France,   Greece,   Jordan,   Portugal,   Russian Federation,   Spain,   Switzerland,   Turkey,   United Kingdom
Israel
 
NCT00289991
A1501073
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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