search
Back to results

Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

Primary Purpose

Aspergillosis, Invasive Fungal Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Isavuconazole
Voriconazole
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aspergillosis focused on measuring Invasive fungal disease, BAL8557, Isavuconazole, ASP9766, Filamentous fungi, Phase III, Aspergillus species

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Alabama
  • University of California at San Francisco
  • University of Chicago, Division of Infectious Diseases
  • Indiana BMT
  • Springfield Clinic LLP
  • Infectious Disease of Indiana
  • Brigham & Womens Hospital
  • Upstate Infectious Diseases Association LLP
  • Regional Infection Diseases Infusion Center Inc.
  • University of Texas MD Anderson Cancer Center
  • Hospital Italiano de Buenos Aires
  • Instituto Medico Especializado Alexander Fleming
  • Mater Medical Centre
  • AZ ST Jan
  • Institut Jules Bordet
  • ULB Hospital Erasme
  • Universitair Ziekenhuis Gent
  • Universitaire Ziekenhuizen Leuven
  • Felicio Rocho
  • Santa Casa de Misericordia de Belo Horizonte
  • Hospital das Clinicas da UFPR
  • Hospital de Clinicas da FMUSP - Ribeirao Preto
  • Hospital Universitario Clementino Fraga Filho
  • The Ottawa Hospital - General Campus
  • Hamilton Health Sciences - Henderson Site
  • Hospital Dr. Hernan Henriquez Aravena
  • 3rd Hospital, Peking University
  • The 1st Hospital, Jilin University
  • The Third Xiangya Hospital of Central South University
  • West China Hospital of Sichuan University
  • The Affiliated Union Hospital of Fujian Medical University
  • The First Affiliated Hospital, Med. School, Zhejiang Uni.
  • The First Affiliated Hospital of Nanjing Medical University
  • The 1st Affiliated Hospital of Guangxi Medical University
  • Huashan Hospital, Insitute of Antibiotics
  • No.6 Renmin Hosp. of Shanghai City
  • Chang Hai Hospital
  • Wuhan Union Hospital
  • Alexandria University Hospital
  • National Cancer Institute
  • Nasser Institute
  • Hotel Dieu
  • CHU de Nantes - Hôpital Hôtel Dieu
  • Hôpital Hautepierre
  • Hôpital de brabois adultes
  • Universitaetsklinikum Aachen
  • Charité Universitaetsmedizin Berlin- Campus Charité Mitte
  • Universitaet Koeln
  • Universitaetsklinik Leipzig
  • Klinikum Schwabing
  • Medizinische klinik und Polyklinik II
  • Petz Aladar Megyei Oktato Korhaz
  • Szegedi Tudomanyegyetem
  • Apollo Hospitals
  • Sterling Hospital
  • Kasturba Medical College and Hospital
  • Shirdi Sai Baba Cancer Hospital K. M. C. Hospital
  • Tata Memorial Hopital, Department of Anesthesia
  • Deenanath Mangeshkar Hospital & Research Centre
  • Sahyadri Hospital
  • Rambam Health Care Campus
  • Hadassah Universtiy Hospital - Ein Kerem
  • Rabin MC
  • Chaim Sheba Medical Center
  • Sourasky MC Ichilov Hospital Tel Aviv
  • Unità Funzionale di Ematologia; Azienda Ospedaliera Universitaria Careggi
  • Azienda Ospedaliera Ospedale Niguarda Ca' Granda
  • Gachon University Gil Hospital
  • Samsung Medical Center
  • The Catholic University of Korea, St. Mary's Hospital
  • Asan Medical Center
  • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Samodzielny Publiczny Centralny Szpital Kliniczny
  • State Institution "Hematology Research Center" RAMS
  • Republican Hospital named after V.A. Baranov
  • Leningrad Regional Hospital
  • St-Petersburg MA Postgraduate Education
  • Songklanagarind Hospital
  • Maharat Nakhon Ratchasima Hospital
  • Srinagarind Hospital
  • Maharaj Nakorn Chiang Mai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Isavuconazole

Voriconazole

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC)
The DRC was an independent, blinded committee consisting of experts in the field of infectious disease who assessed patients' outcomes. The overall response was based on the DRC-assessed clinical, mycological and radiological responses. Success was defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings, the eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline and a > 50% improvement in radiological response from Baseline (or improvement of at least 25% from Baseline for the Day 42 analysis or End of Treatment if it occurred prior to Day 42). End of treatment (EOT) is the last day of study drug administration. For the Day 42 and Day 84 analyses, any visits that the DRC assessed as Not Done were considered a failure for that visit. A death before Day 42 was also considered a failure, even if the DRC assessed the participant to be a success prior to death.
All-cause Mortality Through Day 84
All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 84 from any cause. Participants with unknown survival status through Day 84 were included as deaths in the calculation.
Percentage of Participants With an Overall Outcome of Success Evaluated by Investigator
Overall response based on investigators' assessments was not derived as it was not deemed necessary because participants overall response status was determined by the DRC. All investigators' assessments of clinical, mycological and radiological responses are analyzed separately (see Outcome Measures 8-10).
Percentage of Participants With a Clinical Response Assessed by the DRC
Blinded assessments of clinical symptoms and physical findings of invasive fungal disease were performed by the independent DRC. Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening. Participants with no attributable signs and symptoms present at Baseline and no symptoms attributable to invasive fungal disease (IFD) developed post-baseline were classified as "Not Applicable." End of treatment is the last day of study drug administration.
Percentage of Participants With a Mycological Response Assessed by the DRC
Blinded mycological assessments of the participant's invasive fungal disease status were performed by the independent DRC using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site. Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline were classified as "Not Applicable". End of treatment is the last day of study drug administration.
Percentage of Participants With a Radiological Response Assessed by the DRC
Independent reviews of radiology assessments were completed by radiology experts which were provided to the independent, blinded DRC. Blinded radiological assessments were performed by the DRC. Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Participants without any radiology at Baseline were considered "Not Applicable." End of Treatment is the last day of study drug administration.
Percentage of Participants With a Clinical Response Assessed by the Investigator
Assessment of clinical symptoms and physical findings of invasive fungal disease were performed by the investigator. Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening, or if results were unavailable or the participant was unevaluable. Participants with no attributable signs and symptoms present at Baseline were classified as "Not Applicable." End of treatment is the last day of study drug administration.
Percentage of Participants With a Mycological Response Assessed by the Investigator
Mycological assessments of the participant's invasive fungal disease status were performed by the investigator using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site. Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline, or no mycological follow-up results available or indeterminate results were classified as "Not Applicable". End of treatment is the last day of study drug administration.
Percentage of Participants With a Radiological Response Assessed by the Investigator
Radiological assessments were performed by the investigator. Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Failure is defined as a < 25% improvement at any time or results not available. Participants with no signs on radiological images at Baseline were considered "Not Applicable." End of Treatment is the last day of study drug administration.
Number of Participants With Adverse Events, Reported by System Organ Class

Full Information

First Posted
December 18, 2006
Last Updated
March 25, 2019
Sponsor
Astellas Pharma Inc
Collaborators
Basilea Pharmaceutica International Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT00412893
Brief Title
Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 7, 2007 (Actual)
Primary Completion Date
March 28, 2013 (Actual)
Study Completion Date
March 28, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Basilea Pharmaceutica International Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Acute invasive fungal infections caused by aspergillus, zygomycetes and other filamentous fungi remain life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. This study investigates the efficacy and safety of isavuconazole in the treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspergillosis, Invasive Fungal Infection
Keywords
Invasive fungal disease, BAL8557, Isavuconazole, ASP9766, Filamentous fungi, Phase III, Aspergillus species

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
527 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isavuconazole
Arm Type
Experimental
Arm Description
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.
Arm Title
Voriconazole
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Isavuconazole
Other Intervention Name(s)
ASP9766, BAL8557
Intervention Description
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
Intervention Type
Drug
Intervention Name(s)
Voriconazole
Other Intervention Name(s)
VFend
Intervention Description
Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
Primary Outcome Measure Information:
Title
All-cause Mortality Through Day 42
Description
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.
Time Frame
Through Day 42
Secondary Outcome Measure Information:
Title
Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC)
Description
The DRC was an independent, blinded committee consisting of experts in the field of infectious disease who assessed patients' outcomes. The overall response was based on the DRC-assessed clinical, mycological and radiological responses. Success was defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings, the eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline and a > 50% improvement in radiological response from Baseline (or improvement of at least 25% from Baseline for the Day 42 analysis or End of Treatment if it occurred prior to Day 42). End of treatment (EOT) is the last day of study drug administration. For the Day 42 and Day 84 analyses, any visits that the DRC assessed as Not Done were considered a failure for that visit. A death before Day 42 was also considered a failure, even if the DRC assessed the participant to be a success prior to death.
Time Frame
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Title
All-cause Mortality Through Day 84
Description
All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 84 from any cause. Participants with unknown survival status through Day 84 were included as deaths in the calculation.
Time Frame
Through Day 84
Title
Percentage of Participants With an Overall Outcome of Success Evaluated by Investigator
Description
Overall response based on investigators' assessments was not derived as it was not deemed necessary because participants overall response status was determined by the DRC. All investigators' assessments of clinical, mycological and radiological responses are analyzed separately (see Outcome Measures 8-10).
Time Frame
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Title
Percentage of Participants With a Clinical Response Assessed by the DRC
Description
Blinded assessments of clinical symptoms and physical findings of invasive fungal disease were performed by the independent DRC. Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening. Participants with no attributable signs and symptoms present at Baseline and no symptoms attributable to invasive fungal disease (IFD) developed post-baseline were classified as "Not Applicable." End of treatment is the last day of study drug administration.
Time Frame
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Title
Percentage of Participants With a Mycological Response Assessed by the DRC
Description
Blinded mycological assessments of the participant's invasive fungal disease status were performed by the independent DRC using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site. Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline were classified as "Not Applicable". End of treatment is the last day of study drug administration.
Time Frame
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Title
Percentage of Participants With a Radiological Response Assessed by the DRC
Description
Independent reviews of radiology assessments were completed by radiology experts which were provided to the independent, blinded DRC. Blinded radiological assessments were performed by the DRC. Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Participants without any radiology at Baseline were considered "Not Applicable." End of Treatment is the last day of study drug administration.
Time Frame
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Title
Percentage of Participants With a Clinical Response Assessed by the Investigator
Description
Assessment of clinical symptoms and physical findings of invasive fungal disease were performed by the investigator. Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening, or if results were unavailable or the participant was unevaluable. Participants with no attributable signs and symptoms present at Baseline were classified as "Not Applicable." End of treatment is the last day of study drug administration.
Time Frame
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Title
Percentage of Participants With a Mycological Response Assessed by the Investigator
Description
Mycological assessments of the participant's invasive fungal disease status were performed by the investigator using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site. Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline, or no mycological follow-up results available or indeterminate results were classified as "Not Applicable". End of treatment is the last day of study drug administration.
Time Frame
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Title
Percentage of Participants With a Radiological Response Assessed by the Investigator
Description
Radiological assessments were performed by the investigator. Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Failure is defined as a < 25% improvement at any time or results not available. Participants with no signs on radiological images at Baseline were considered "Not Applicable." End of Treatment is the last day of study drug administration.
Time Frame
Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.
Title
Number of Participants With Adverse Events, Reported by System Organ Class
Time Frame
From the first study drug administration until 28 days after the last dose of study drug. The median duration of study drug administration was 45 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0006
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Chicago, Division of Infectious Diseases
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana BMT
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Springfield Clinic LLP
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Infectious Disease of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
Brigham & Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Upstate Infectious Diseases Association LLP
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Regional Infection Diseases Infusion Center Inc.
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Buenos Aires
ZIP/Postal Code
C1039AAO
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1157ADP
Country
Argentina
City
Buenos Aires
Country
Argentina
City
Capital Federal
ZIP/Postal Code
C1180AAV
Country
Argentina
City
Capital Federal
ZIP/Postal Code
C1405DCS
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autonoma
ZIP/Postal Code
1181
Country
Argentina
Facility Name
Instituto Medico Especializado Alexander Fleming
City
Ciudad Autonoma
ZIP/Postal Code
1426
Country
Argentina
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Mater Medical Centre
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
AZ ST Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
ULB Hospital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Felicio Rocho
City
Belo Horizonte
ZIP/Postal Code
30110-908
Country
Brazil
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Hospital das Clinicas da UFPR
City
Curitiba
ZIP/Postal Code
80060-150
Country
Brazil
Facility Name
Hospital de Clinicas da FMUSP - Ribeirao Preto
City
Ribeirão Preto
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Hospital Universitario Clementino Fraga Filho
City
Rio de Janeiro
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Hamilton Health Sciences - Henderson Site
City
Hamilton
ZIP/Postal Code
L8V 1C3
Country
Canada
City
Santiago
Country
Chile
Facility Name
Hospital Dr. Hernan Henriquez Aravena
City
Temuco
ZIP/Postal Code
4780000
Country
Chile
City
Valdivia
ZIP/Postal Code
5090000
Country
Chile
Facility Name
3rd Hospital, Peking University
City
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
The 1st Hospital, Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
The Affiliated Union Hospital of Fujian Medical University
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
The First Affiliated Hospital, Med. School, Zhejiang Uni.
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
ZIP/Postal Code
310009
Country
China
Facility Name
The 1st Affiliated Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
Huashan Hospital, Insitute of Antibiotics
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
No.6 Renmin Hosp. of Shanghai City
City
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Name
Chang Hai Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Alexandria University Hospital
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Facility Name
Nasser Institute
City
Cairo
ZIP/Postal Code
12655
Country
Egypt
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hotel Dieu
City
Nantes Cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nantes - Hôpital Hôtel Dieu
City
Nantes Cedex
ZIP/Postal Code
44035
Country
France
Facility Name
Hôpital Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hôpital de brabois adultes
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Universitaetsklinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Charité Universitaetsmedizin Berlin- Campus Charité Mitte
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitaet Koeln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsklinik Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Klinikum Schwabing
City
Muenchen
ZIP/Postal Code
81737
Country
Germany
Facility Name
Medizinische klinik und Polyklinik II
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Györ
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Apollo Hospitals
City
Hyderabad
State/Province
Andh Prad
ZIP/Postal Code
500033
Country
India
Facility Name
Sterling Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380052
Country
India
Facility Name
Kasturba Medical College and Hospital
City
Mangalore
State/Province
Karna
ZIP/Postal Code
575001
Country
India
Facility Name
Shirdi Sai Baba Cancer Hospital K. M. C. Hospital
City
Manipal
State/Province
Karna
ZIP/Postal Code
576104
Country
India
Facility Name
Tata Memorial Hopital, Department of Anesthesia
City
Mumbai
State/Province
Mahara
ZIP/Postal Code
400012
Country
India
Facility Name
Deenanath Mangeshkar Hospital & Research Centre
City
Pune
State/Province
Mahara
ZIP/Postal Code
411004
Country
India
Facility Name
Sahyadri Hospital
City
Pune
State/Province
Mahara
ZIP/Postal Code
411004
Country
India
City
Noida
State/Province
Uttar Prad
ZIP/Postal Code
201301
Country
India
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Universtiy Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
91200
Country
Israel
Facility Name
Rabin MC
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sourasky MC Ichilov Hospital Tel Aviv
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Unità Funzionale di Ematologia; Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Gachon University Gil Hospital
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
City
Kuala Lumpur
ZIP/Postal Code
68000
Country
Malaysia
City
Mexico
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez
City
Monterrey
ZIP/Postal Code
64040
Country
Mexico
City
Nijmegen
ZIP/Postal Code
6525
Country
Netherlands
City
Palmerston North
ZIP/Postal Code
4442
Country
New Zealand
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
State Institution "Hematology Research Center" RAMS
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Republican Hospital named after V.A. Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Leningrad Regional Hospital
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
St-Petersburg MA Postgraduate Education
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Songklanagarind Hospital
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Maharat Nakhon Ratchasima Hospital
City
Muang
ZIP/Postal Code
30000
Country
Thailand
Facility Name
Srinagarind Hospital
City
Muang
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Muang
ZIP/Postal Code
50200
Country
Thailand
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
28472247
Citation
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. Erratum In: Clin Infect Dis. 2017 Oct 15;65(8):1431-1433.
Results Reference
derived
PubMed Identifier
26684607
Citation
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.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=52
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

We'll reach out to this number within 24 hrs