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A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.


Phase 3
18 Years
N/A
Not Enrolling
Both
Invasive Fungal Infection, Aspergillosis

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Trial Information

A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.


Acute invasive fungal infections caused by aspergillus, zygomycetes and other filamentous
fungi remain to be a life threatening diseases. Early treatment with highly effective
anti-fungals reduces mortality. Isavuconazole is not yet registered for the treatment of
fungal infections. This study investigates the efficacy and safety of isavuconazole in the
treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi.
Patients are randomized to receive either isavuconazole or voriconazole. The study compares
the safety and efficacy of both drugs.


Inclusion Criteria:



- Patients must have probable or proven invasive fungal disease caused by Aspergillus
species or other filamentous fungi

- Female patients must be non-lactating and at no risk for pregnancy

Exclusion Criteria:

- Patients with invasive fungal infections other than Aspergillus species or other
filamentous fungi

- Patients with chronic aspergillosis, or aspergilloma or allergic bronchopulmonary
aspergillosis

- Patients who have received more than 4 days of systemic antifungal therapy other than
fluconazole within the 7 days prior to the first administration of study medication

- Patients previously enrolled in a Phase III study with isavuconazole

- Patients with a body weight

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

All-cause mortality through Day 42

Outcome Time Frame:

Up to Day 42

Safety Issue:

No

Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

9766-CL-0104

NCT ID:

NCT00412893

Start Date:

December 2006

Completion Date:

March 2013

Related Keywords:

  • Invasive Fungal Infection
  • Aspergillosis
  • Phase III
  • Invasive fungal disease
  • Aspergillus species
  • Filamentous fungi
  • ASP9766
  • BAL8557
  • Isavuconazole
  • Aspergillosis
  • Mycoses

Name

Location

University of AlabamaBirmingham, Alabama  
Infectious Disease of IndianaIndianapolis, Indiana  46218
Boston, Massachusetts  
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
University of California at San FranciscoSan Francisco, California  94115
University of Chicago, Division of Infectious DiseasesChicago, Illinois  60637
Indiana BMTSpringfield, Illinois  62701
Brigham & Womens HospitalBoston, Massachusetts  02115
Upstate Infectious Diseases Association LLPAlbany, New York  12208
Regional Infection Diseases Infusion Center Inc.Lima, Ohio  45801
Springfield Clinic LLPSpringfield, Illinois  62703