Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
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.
3 other identifiers
interventional
527
26 countries
107
Brief Summary
The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2007
Longer than P75 for phase_3
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2006
CompletedFirst Posted
Study publicly available on registry
December 19, 2006
CompletedStudy Start
First participant enrolled
March 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2013
CompletedResults Posted
Study results publicly available
March 31, 2015
CompletedDecember 10, 2024
November 1, 2024
6.1 years
December 18, 2006
March 19, 2015
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause Mortality Through Day 42
All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 42 from any cause. Participants with unknown survival status through Day 42 were included as deaths in the calculation.
Through Day 42
Secondary Outcomes (10)
Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC)
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
All-cause Mortality Through Day 84
Through Day 84
Percentage of Participants With an Overall Outcome of Success Evaluated by Investigator
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Percentage of Participants With a Clinical Response Assessed by the DRC
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Percentage of Participants With a Mycological Response Assessed by the DRC
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
- +5 more secondary outcomes
Study Arms (2)
Isavuconazole
EXPERIMENTALParticipants 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.
Voriconazole
ACTIVE COMPARATORParticipants 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.
Interventions
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
Eligibility Criteria
You may qualify if:
- Patients must have proven, probable or possible invasive fungal disease caused by Aspergillus species or other filamentous fungi
- Female patients must be non-lactating and at no risk for pregnancy
You may not qualify if:
- Patients with invasive fungal infections other than Aspergillus species or other filamentous fungi
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Basilea Pharmaceutica International Ltdcollaborator
Study Sites (107)
University of Alabama
Birmingham, Alabama, 35294-0006, United States
University of California at San Francisco
San Francisco, California, 94143, United States
University of Chicago, Division of Infectious Diseases
Chicago, Illinois, 60637, United States
Indiana BMT
Springfield, Illinois, 62703, United States
Springfield Clinic LLP
Springfield, Illinois, 62703, United States
Infectious Disease of Indiana
Indianapolis, Indiana, 46280, United States
Brigham & Womens Hospital
Boston, Massachusetts, 02115, United States
Unknown Facility
Worcester, Massachusetts, 01655, United States
Upstate Infectious Diseases Association LLP
Albany, New York, 12208, United States
Regional Infection Diseases Infusion Center Inc.
Lima, Ohio, 45801, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Unknown Facility
Buenos Aires, C1039AAO, Argentina
Unknown Facility
Buenos Aires, C1157ADP, Argentina
Unknown Facility
Buenos Aires, Argentina
Unknown Facility
Capital Federal, C1180AAV, Argentina
Unknown Facility
Capital Federal, C1405DCS, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma, 1181, Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma, 1426, Argentina
Unknown Facility
Perth, 6000, Australia
Mater Medical Centre
South Brisbane, 4101, Australia
Unknown Facility
Woolloongabba, 4102, Australia
AZ ST Jan
Bruges, 8000, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
ULB Hospital Erasme
Brussels, 1070, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, 3000, Belgium
Felicio Rocho
Belo Horizonte, 30110-908, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221, Brazil
Hospital das Clinicas da UFPR
Curitiba, 80060-150, Brazil
Hospital de Clinicas da FMUSP - Ribeirao Preto
Ribeirão Preto, 14048-900, Brazil
Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, 21941-913, Brazil
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Hamilton Health Sciences - Henderson Site
Hamilton, L8V 1C3, Canada
Unknown Facility
Santiago, Chile
Hospital Dr. Hernan Henriquez Aravena
Temuco, 4780000, Chile
Unknown Facility
Valdivia, 5090000, Chile
3rd Hospital, Peking University
Beijing, 100083, China
The 1st Hospital, Jilin University
Changchun, 130021, China
The Third Xiangya Hospital of Central South University
Changsha, 410013, China
West China Hospital of Sichuan University
Chengdu, 610041, China
The Affiliated Union Hospital of Fujian Medical University
Fuzhou, 350001, China
The First Affiliated Hospital, Med. School, Zhejiang Uni.
Hangzhou, 310003, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, 310009, China
The 1st Affiliated Hospital of Guangxi Medical University
Nanning, 530021, China
Huashan Hospital, Insitute of Antibiotics
Shanghai, 200040, China
No.6 Renmin Hosp. of Shanghai City
Shanghai, 200233, China
Chang Hai Hospital
Shanghai, 200433, China
Wuhan Union Hospital
Wuhan, 430022, China
Alexandria University Hospital
Alexandria, 21131, Egypt
National Cancer Institute
Cairo, 11796, Egypt
Nasser Institute
Cairo, 12655, Egypt
Unknown Facility
Dijon, 21079, France
CHU de Nantes - Hôpital Hôtel Dieu
Nantes, 44035, France
Hotel Dieu
Nantes, 44093, France
Hôpital Hautepierre
Strasbourg, 67098, France
Hôpital de brabois adultes
Vandœuvre-lès-Nancy, 54511, France
Universitaetsklinikum Aachen
Aachen, 52074, Germany
Charité Universitaetsmedizin Berlin- Campus Charité Mitte
Berlin, 12200, Germany
Universitaet Koeln
Cologne, 50937, Germany
Universitaetsklinik Leipzig
Leipzig, 04289, Germany
Unknown Facility
Lübeck, 23538, Germany
Klinikum Schwabing
München, 81737, Germany
Medizinische klinik und Polyklinik II
Würzburg, 97080, Germany
Unknown Facility
Budapest, 1094, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9024, Hungary
Szegedi Tudomanyegyetem
Szeged, 6720, Hungary
Apollo Hospitals
Hyderabad, Andh Prad, 500033, India
Sterling Hospital
Ahmedabad, Gujarat, 380052, India
Kasturba Medical College and Hospital
Mangalore, Karna, 575001, India
Shirdi Sai Baba Cancer Hospital K. M. C. Hospital
Manipal, Karna, 576104, India
Tata Memorial Hopital, Department of Anesthesia
Mumbai, Mahara, 400012, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Mahara, 411004, India
Sahyadri Hospital
Pune, Mahara, 411004, India
Unknown Facility
Noida, Uttar Prad, 201301, India
Rambam Health Care Campus
Haifa, 31096, Israel
Hadassah Universtiy Hospital - Ein Kerem
Jerusalem, 91200, Israel
Rabin MC
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Sourasky MC Ichilov Hospital Tel Aviv
Tel Aviv, 64239, Israel
Unità Funzionale di Ematologia; Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, 20162, Italy
Unknown Facility
Kuala Lumpur, 59100, Malaysia
Unknown Facility
Kuala Lumpur, 68000, Malaysia
Unknown Facility
México, 06726, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64040, Mexico
Unknown Facility
Nijmegen, 6525, Netherlands
Unknown Facility
Palmerston North, 4442, New Zealand
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, 02-097, Poland
State Institution "Hematology Research Center" RAMS
Moscow, 125167, Russia
Republican Hospital named after V.A. Baranov
Petrozavodsk, 185019, Russia
Leningrad Regional Hospital
Saint Petersburg, 194291, Russia
St-Petersburg MA Postgraduate Education
Saint Petersburg, 194291, Russia
Unknown Facility
Saint Petersburg, 197089, Russia
Gachon University Gil Hospital
Incheon, 405-760, South Korea
Unknown Facility
Seoul, 120-752, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
The Catholic University of Korea, St. Mary's Hospital
Seoul, 137-701, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Unknown Facility
Salamanca, 37007, Spain
Unknown Facility
Zurich, 8091, Switzerland
Songklanagarind Hospital
Hat Yai, 90110, Thailand
Unknown Facility
Khon Kaen, 40002, Thailand
Maharat Nakhon Ratchasima Hospital
Muang, 30000, Thailand
Srinagarind Hospital
Muang, 40002, Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang, 50200, Thailand
Unknown Facility
Songkhla, 90110, Thailand
Unknown Facility
Istanbul, 34662, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 37185921DERIVEDKovanda 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.
PMID: 28472247DERIVEDMaertens 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.
PMID: 26684607DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Results Point of Contact
- Title
- Medical Head Immunology, Transplant and Infectious Disease Therapeutic Area
- Organization
- Astellas Pharma Global Development, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2006
First Posted
December 19, 2006
Study Start
March 7, 2007
Primary Completion
March 28, 2013
Study Completion
March 28, 2013
Last Updated
December 10, 2024
Results First Posted
March 31, 2015
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.