Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
NCT ID: NCT00412893
Last Updated: 2024-12-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
527 participants
INTERVENTIONAL
2007-03-07
2013-03-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Isavuconazole
Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
Isavuconazole
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
Voriconazole
Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
Voriconazole
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
Interventions
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Isavuconazole
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
Voriconazole
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female patients must be non-lactating and at no risk for pregnancy
Exclusion Criteria
* Evidence of hepatic dysfunction at Baseline or moderate to severe renal dysfunction
* 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 \</= 40 kg
18 Years
ALL
No
Sponsors
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Basilea Pharmaceutica International Ltd
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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University of Alabama
Birmingham, Alabama, United States
University of California at San Francisco
San Francisco, California, United States
University of Chicago, Division of Infectious Diseases
Chicago, Illinois, United States
Indiana BMT
Springfield, Illinois, United States
Springfield Clinic LLP
Springfield, Illinois, United States
Infectious Disease of Indiana
Indianapolis, Indiana, United States
Brigham & Womens Hospital
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Upstate Infectious Diseases Association LLP
Albany, New York, United States
Regional Infection Diseases Infusion Center Inc.
Lima, Ohio, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Capital Federal, , Argentina
Capital Federal, , Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma, , Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma, , Argentina
Perth, , Australia
Mater Medical Centre
South Brisbane, , Australia
Woolloongabba, , Australia
AZ ST Jan
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
ULB Hospital Erasme
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Felicio Rocho
Belo Horizonte, , Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, , Brazil
Hospital das Clinicas da UFPR
Curitiba, , Brazil
Hospital de Clinicas da FMUSP - Ribeirao Preto
Ribeirão Preto, , Brazil
Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, , Brazil
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Hamilton Health Sciences - Henderson Site
Hamilton, , Canada
Santiago, , Chile
Hospital Dr. Hernan Henriquez Aravena
Temuco, , Chile
Valdivia, , Chile
3rd Hospital, Peking University
Beijing, , China
The 1st Hospital, Jilin University
Changchun, , China
The Third Xiangya Hospital of Central South University
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
The Affiliated Union Hospital of Fujian Medical University
Fuzhou, , China
The First Affiliated Hospital, Med. School, Zhejiang Uni.
Hangzhou, , China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, , China
The 1st Affiliated Hospital of Guangxi Medical University
Nanning, , China
Huashan Hospital, Insitute of Antibiotics
Shanghai, , China
No.6 Renmin Hosp. of Shanghai City
Shanghai, , China
Chang Hai Hospital
Shanghai, , China
Wuhan Union Hospital
Wuhan, , China
Alexandria University Hospital
Alexandria, , Egypt
National Cancer Institute
Cairo, , Egypt
Nasser Institute
Cairo, , Egypt
Dijon, , France
CHU de Nantes - Hôpital Hôtel Dieu
Nantes, , France
Hotel Dieu
Nantes, , France
Hôpital Hautepierre
Strasbourg, , France
Hôpital de brabois adultes
Vandœuvre-lès-Nancy, , France
Universitaetsklinikum Aachen
Aachen, , Germany
Charité Universitaetsmedizin Berlin- Campus Charité Mitte
Berlin, , Germany
Universitaet Koeln
Cologne, , Germany
Universitaetsklinik Leipzig
Leipzig, , Germany
Lübeck, , Germany
Klinikum Schwabing
München, , Germany
Medizinische klinik und Polyklinik II
Würzburg, , Germany
Budapest, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Szegedi Tudomanyegyetem
Szeged, , Hungary
Apollo Hospitals
Hyderabad, Andh Prad, India
Sterling Hospital
Ahmedabad, Gujarat, India
Kasturba Medical College and Hospital
Mangalore, Karna, India
Shirdi Sai Baba Cancer Hospital K. M. C. Hospital
Manipal, Karna, India
Tata Memorial Hopital, Department of Anesthesia
Mumbai, Mahara, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Mahara, India
Sahyadri Hospital
Pune, Mahara, India
Noida, Uttar Prad, India
Rambam Health Care Campus
Haifa, , Israel
Hadassah Universtiy Hospital - Ein Kerem
Jerusalem, , Israel
Rabin MC
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Sourasky MC Ichilov Hospital Tel Aviv
Tel Aviv, , Israel
Unità Funzionale di Ematologia; Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, , Italy
Kuala Lumpur, , Malaysia
Kuala Lumpur, , Malaysia
México, , Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, , Mexico
Nijmegen, , Netherlands
Palmerston North, , New Zealand
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, , Poland
State Institution "Hematology Research Center" RAMS
Moscow, , Russia
Republican Hospital named after V.A. Baranov
Petrozavodsk, , Russia
Leningrad Regional Hospital
Saint Petersburg, , Russia
St-Petersburg MA Postgraduate Education
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Gachon University Gil Hospital
Incheon, , South Korea
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, St. Mary's Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Salamanca, , Spain
Zurich, , Switzerland
Songklanagarind Hospital
Hat Yai, , Thailand
Khon Kaen, , Thailand
Maharat Nakhon Ratchasima Hospital
Muang, , Thailand
Srinagarind Hospital
Muang, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang, , Thailand
Songkhla, , Thailand
Istanbul, , Turkey (Türkiye)
Countries
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References
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Hamed K, Engelhardt M, Kovanda LL, Huang JJ, Yan J, Aram JA. Post-hoc analysis of the safety and efficacy of isavuconazole in older patients with invasive fungal disease from the VITAL and SECURE studies. Sci Rep. 2023 Apr 25;13(1):6730. doi: 10.1038/s41598-023-31788-1.
Kovanda LL, Kolamunnage-Dona R, Neely M, Maertens J, Lee M, Hope WW. Pharmacodynamics of Isavuconazole for Invasive Mold Disease: Role of Galactomannan for Real-Time Monitoring of Therapeutic Response. Clin Infect Dis. 2017 Jun 1;64(11):1557-1563. doi: 10.1093/cid/cix198.
Maertens JA, Raad II, Marr KA, Patterson TF, Kontoyiannis DP, Cornely OA, Bow EJ, Rahav G, Neofytos D, Aoun M, Baddley JW, Giladi M, Heinz WJ, Herbrecht R, Hope W, Karthaus M, Lee DG, Lortholary O, Morrison VA, Oren I, Selleslag D, Shoham S, Thompson GR 3rd, Lee M, Maher RM, Schmitt-Hoffmann AH, Zeiher B, Ullmann AJ. Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial. Lancet. 2016 Feb 20;387(10020):760-9. doi: 10.1016/S0140-6736(15)01159-9. Epub 2015 Dec 10.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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WSA-CS-004
Identifier Type: OTHER
Identifier Source: secondary_id
2006-003868-59
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
9766-CL-0104
Identifier Type: -
Identifier Source: org_study_id