Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
This study has been completed.
Sponsor:
Astellas Pharma Inc
Collaborator:
Basilea Pharmaceutica
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00412893
First received: December 18, 2006
Last updated: April 26, 2013
Last verified: April 2013
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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:
|
| 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
Show 107 Study Locations
Show 107 Study LocationsSponsors 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: | April 26, 2013 |
| 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: 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 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 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 May 23, 2013