Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

Official Title: “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.”

The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.

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.

Intervention(s) in this Clinical Trial

• Drug: Isavuconazole
  • Drug treatment
• Drug: Voriconazole
  • Drug treatment

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Isavuconazole
• Active Comparator: Voriconazole

Primary Measures

• All-cause mortality through Day 42
  • Time Frame: Up to Day 42
    Safety Issue?: No

Secondary Measures

• All-cause mortality rate at Day 84
  • Time Frame: Day 84
    Safety Issue?: No
• Overall outcome of treatment evaluated by Data Review Committee (DRC)
  • Time Frame: Day 42, End of Therapy (maximum of 84 days) and Day 84
    Safety Issue?: No
• Overall outcome of treatment evaluated by Investigator
  • Time Frame: Day 42, End of Therapy (maximum of 84 days) and Day 84
    Safety Issue?: No
• Clinical Response
  • Time Frame: Day 42 and end of treatment (up to Day 84)
    Safety Issue?: No
• Mycological Response
  • Time Frame: Day 42 and end of treatment (up to Day 84)
    Safety Issue?: No
• Radiological Response
  • Time Frame: Day 42 and end of treatment (up to Day 84)
    Safety Issue?: No

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 </= 40kg

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Astellas Pharma Inc Industry

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Astellas Pharma Global Development  

Overall Contact: Astellas Pharma Global Development 800-888-7704 clintrials.info@us.astellas.com

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00412893

Study ID Number: 9766-CL-0104

ClinicalTrials.gov Identifier: NCT00412893

Health Authority: United States: Food and Drug Administration