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Open Label Study of Isavuconazole in the Treatment of Patients With Aspergillosis and Renal Impairment or of Patients With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

Phase 3
18 Years
Open (Enrolling)
Aspergillosis, Invasive Fungal Infections

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Trial Information

Open Label Study of Isavuconazole in the Treatment of Patients With Aspergillosis and Renal Impairment or of Patients With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

Acute invasive fungal infections caused by aspergillus, rare moulds, yeasts or dimorphic
fungi are life threatening diseases. Early treatment with highly effective anti-fungals
reduces mortality. Isavuconazole is not approved for the treatment of fungal infections.
This study investigates the safety and efficacy of isavuconazole in patients with
aspergillosis and renal impairment, and in patients suffering from invasive infections from
rare fungi.

Inclusion Criteria:

- Patients meeting EORTC/MSG (European Organization for the Research and Treatment of
Cancer/Mycoses Study Group) definition of proven or culture positive probable IFD
(invasive fungal disease) caused by rare molds, yeasts, or dimorphic fungi (i.e.
fungal pathogens other than Aspergillus or Candida species) whether renally impaired
or not (including dialysis) who require primary therapy for their IFD at the time of


- Patients who have proven or probable zygomycosis, whether renally impaired or not
(including dialysis), who require primary therapy. Zygomycosis must be documented by
culture or histology / cytology.

Exclusion Criteria:

- a known condition of the patient that may jeopardize adherence to the protocol

- Patients who are unlikely to survive 30 days

- Patients with a body weight < 40 kg

- Women who are pregnant or breastfeeding

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall outcome of treatment evaluated by Data Review Committee (DRC)

Outcome Description:

Based on the assessments of clinical, mycological and radiological response

Outcome Time Frame:

Day 42

Safety Issue:


Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development


United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

July 2013

Related Keywords:

  • Aspergillosis
  • Invasive Fungal Infections
  • Aspergillosis
  • invasive fungal infections caused by rare molds, rare yeasts
  • or by dimorphic fungi
  • Isavuconazole
  • ASP9766
  • BAL8557
  • Aspergillosis
  • Mycoses



Infectious Disease of Indiana Indianapolis, Indiana  46218
Henry Ford Hospital Detroit, Michigan  48202
New York Medical College Valhalla, New York  10595
Rush University Medical Center Chicago, Illinois  60612-3824
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Ochsner Clinic Foundation New Orleans, Louisiana  70121
City of Hope National Medical Center Los Angeles, California  91010
University of Minnesota Minneapolis, Minnesota  55455
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Oregon Health & Science University Portland, Oregon  97201
Fountain Valley, California  92708
University of Colorado Health Sciences Center Denver, Colorado  80262
Bend Memorial Clinic Bend, Oregon  97701
Cleveland Clinic Cleveland, Ohio  44195
Milwaukee, Wisconsin  
California Pacific Medical Center San Francisco, California  94115
University of Texas MD Anderson Cancer Center Houston, Texas  77030
University of California at San Francisco San Francisco, California  94115
Wayne State University School of Medicine Detroit, Michigan  48201-2097
University of Pennsylvania Health System Philadelphia, Pennsylvania  19104
UMass Memorial Medical Center Worcester, Massachusetts  01655
University of California - Los Angeles Los Angeles, California  90095
University of Wisconsin School of Medicine and Public Health Madison, Wisconsin  53792-5666
University of California Davis Health System Sacramento, California  95817
Stanford University Hospital Stanford, California  94303
Emory Hospital Atlanta, Georgia  30322
University of Chicago, Division of Infectious Diseases Chicago, Illinois  60637
Brigham & Womens Hospital Boston, Massachusetts  02115
Upstate Infectious Diseases Association LLP Albany, New York  12208
Regional Infection Diseases Infusion Center Inc. Lima, Ohio  45801
Temple University Health Sciences Philadelphia, Pennsylvania  19140
Penn Memory Center Philadelphia, Pennsylvania  19104
Fred Hutchinson Cancer Research Center, Clinical Research Seattle, Washington  98109
Indiana BMT Beech Grove, Indiana  46107
Remington-Davis Inc. Columbus, Ohio  43215
Sloan Kettering Cancer Center New York, New York  10065
University of Pittsburgh Medical Center Health System Pittsburgh, Pennsylvania  15213