Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
This study is currently recruiting participants.
Verified July 2012 by Astellas Pharma Inc

First Received on December 18, 2006.  
Last Updated on July 26, 2012  
History of Changes
Sponsor: Astellas Pharma Inc
Collaborator: Basilea Pharmaceutica
Information provided by (Responsible Party): Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00412893
  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 ]

Estimated Enrollment: 510
Study Start Date: December 2006
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 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

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

Contacts
Contact: Astellas Pharma Global Development 800-888-7704 ext 5473 clintrials.info@us.astellas.com

 
Show 255 Study Locations

Sponsors and Collaborators
Astellas Pharma Inc
Basilea Pharmaceutica
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: July 26, 2012
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 Publica de Chile
China: State Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
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)
Peru: Instituto Nacional de Salud
Poland: The Central Register of Clinical Trials
Russia: Ministry of Health and Social Development of the Russian Federation
Saudi Arabia: Ministry of Health
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

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 August 21, 2012

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