Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

This study has been completed.
Sponsor:
Collaborator:
Basilea Pharmaceutica International Ltd
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00412893
First received: December 18, 2006
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Invasive Fungal Infection
Aspergillosis
Drug: Isavuconazole
Drug: Voriconazole
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • All-cause mortality through Day 42 [ Time Frame: Up to Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality rate at Day 84 [ Time Frame: Day 84 ] [ Designated as 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 ] [ Designated as safety issue: No ]
    Based on the assessments of clinical, mycological and radiological response

  • Overall outcome of treatment evaluated by Investigator [ Time Frame: Day 42, End of Therapy (maximum of 84 days) and Day 84 ] [ Designated as safety issue: No ]
    Based on the assessments of clinical, mycological and radiological response

  • Clinical Response [ Time Frame: Day 42 and end of treatment (up to Day 84) ] [ Designated as safety issue: No ]
  • Mycological Response [ Time Frame: Day 42 and end of treatment (up to Day 84) ] [ Designated as safety issue: No ]
  • Radiological Response [ Time Frame: Day 42 and end of treatment (up to Day 84) ] [ Designated as safety issue: No ]

Enrollment: 527
Study Start Date: December 2006
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Isavuconazole Drug: Isavuconazole
Drug treatment
Other Names:
  • ASP9766
  • BAL8557
Active Comparator: Voriconazole Drug: Voriconazole
Drug treatment
Other Name: VFend

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412893

  Show 107 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Basilea Pharmaceutica International Ltd
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00412893     History of Changes
Other Study ID Numbers: 9766-CL-0104, WSA-CS-004, 2006-003868-59
Study First Received: December 18, 2006
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Egypt: Ministry of Health and Population
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Israel: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Lebanon: Ministry of Public Health
Mexico: Secretaria de Salud
Malaysia: Ministry of Health
New Zealand: Medsafe
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: The Central Register of Clinical Trials
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Phase III
Invasive fungal disease
Aspergillus species
Filamentous fungi
ASP9766
BAL8557
Isavuconazole

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014