Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis - Full Text View

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:

MedlinePlus related topics: Aspergillosis Fungal Infections Molds

Drug Information available for: Voriconazole

U.S. FDA Resources

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:	July 2012
Estimated Primary Completion Date:	July 2012 (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 252 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:	May 2, 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 - French Health Products Safety Agency 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 May 22, 2012