Back to resultsA Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
Primary Purpose
Invasive Mucormycosis, Invasive Aspergillosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Isavuconazonium sulfate
Isavuconazonium sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Invasive Mucormycosis focused on measuring ASP9766, Cresemba, BAL8557, isavuconazonium sulfate
Eligibility Criteria
Inclusion Criteria:
Subject diagnosed with IA or IM. A positive diagnosis is defined as follows:
- Proven, probable or possible IFI per the European Organisation for Research and Treatment of Cancer/Mycoses Study Group [EORTC/MSG], 2008 criteria Note: Subjects with "possible" IFI will be eligible for enrollment; however, diagnostic tests to confirm the invasive fungal disease as "probable" or "proven" according to the EORTC/MSG criteria should be completed within 10 calendar days after the first dose of study drug
- Note: In addition to the criteria set for mycological criteria by the EORTC/MSG in 2008, and only for subjects with an underlying hematologic malignancy or recipients of hematopoietic stem cell transplant (HSCT) who also have clinical and radiologic features consistent with invasive fungal infection, the following are acceptable:
- Galactomannan (GM) levels (optical density index) meeting the below criteria are acceptable mycological evidence for enrollment or upgrading the diagnosis to probable IA:
- 1. A single value for serum or bronchoalveolar lavage (BAL) fluid of ≥ 1.0 or
- 2. Two serum GM values of ≥ 0.5 from two separate samples
- Subject has sufficient venous access to permit intravenous administration of study drug or the ability to swallow oral capsules
A female subject is eligible to participate if not pregnant and at least one of the following conditions applies:
- Not a subject who is of childbearing potential, OR
- Subject who is of childbearing potential who agrees to follow a contraceptive guidance throughout the treatment period and for at least 30 days after the final study drug administration
- Subject and subject's parent(s) or legal guardian agree that the subject will not participate in another interventional study while on treatment with the exception of oncology trials
Exclusion Criteria:
- Subject has familial short QT syndrome, is receiving medications that are known to shorten the QT interval, or has a clinically significant abnormal ECG
Subject has evidence of hepatic dysfunction defined as any of the following:
- Total bilirubin (TBL) ≥ 3 times the upper limit of normal (ULN)
- Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 5 times the ULN
- Known cirrhosis or chronic hepatic failure
- Subject has used strong cytochrome P450 (CYP3A4) inhibitors or inducers such as ketoconazole, high dose ritonavir, rifampin/rifampicin, long acting barbiturates (e.g., phenytoin), carbamazepine and St. John's Wort in the 5 days prior to the first dose of study drug
- Subject has another IFI other than possible, probably or proven IA or IM
- Subject has chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis
Subject has received mould active systemic antifungal therapy, effective against the primary IMI, for more than four days during the seven days preceding the first dose
- Note: Prior use of prophylactic antifungal therapy is acceptable. In case of breakthrough IA while on prophylactic mould-active azole class drugs, additional documentation will be required to be submitted to the sponsor medical monitor or designee to approve subject enrollment
- Subject has known history of allergy, hypersensitivity or any serious reaction to any of the azole class antifungals, or any components of the study drug formulation
- Subject has any condition which makes the subject unsuitable for study participation
- Subject is unlikely to survive 30 days
- Subject has received investigational drug, with the exception of oncology drug trials, or trials with investigational drugs treating graft versus host disease, within 28 days or five half-lives, whichever is longer, prior to screening
Sites / Locations
- Children's Hospital, Los Angeles
- University of California - Los Angeles
- Children's Hospital of Orange County
- Children's National Medical Center
- Ann & Robert H. Lurie Children's Hospital of Chicago
- Site BE32001
- Site BE32002
- Site ES34002
- Site ES34003
- Site ES34001
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Isavuconazonium sulfate
Arm Description
Participants received 10 milligrams/killograms (mg/kg) dose of isavuconazonium sulfate every 8 hours (± 2 hours) on days 1 and 2 for a total of 6 doses (via intravenous or oral administration at the investigator's discretion) followed by once-daily maintenance dose of 10 mg/kg for up to 84 days IA or 180 days IM or until the participant had a successful outcome as judged by the investigator, whichever occured first. The route of administration could have been changed per the investigator's discretion.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a participant administered a study drug, which does not have to have a causal relationship with this treatment. It can be any unfavorable sign, symptom, or disease temporally associated with the use of a medicinal product.
TEAE is defined as an AE observed after starting administration of the study drug through 30 days after the last dose.
Percentage of Participants With All - Cause Mortality Through Day 42
All - Cause Mortality Through Day 42
Secondary Outcome Measures
Percentage of Participants With All - Cause Mortality
EOT was defined as anytime from "day 1 to a maximum of day 180". Data reported in the table below for each category, i.e., Day 84 represented data between Day 1 and Day 84 and for EOT, data represented between Day 1 to the EOT day for each individual. Participants who died after EOT assessment but before reaching Day 84 were included in the data for Day 84 category. Only those deaths that occurred after Day 84 would be included in EOT category if the death occurred during the treatment period (i.e. prior to the EOT).
Percentage of Participants With Overall Response: Adjudication Committee (AC) Assessment
Overall response was based on a composite of clinical, mycological, and radiological responses with success criteria assessed. Success criteria as assessed by AC in:
Clinical response:
Complete: Resolution of all attributable clinical symptoms and physical findings
Partial: Resolution of at Least some of the clinical symptoms and physical findings associated with IFD
Mycological response:
Eradication: No growth of the original (at baseline) causative organism on culture or identified by histology/cytology on post baseline (after day 7) cultures and/or histology/cytology
Presumed eradication: Missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding
Radiological response:
Complete: ≥ 90% improvement
Partial: At least < 25% response at day 42 and at least 50% by Day 84
Percentage of Participants With Clinical Response: AC Assessment
AC Assessed Clinical response was defined as follows:
Success: Complete (if resolution of all attributable clinical symptoms and physical findings occurs); Partial (if resolution of at least some of the clinical symptoms and physical findings associated with IFD)
Failure: Stable (if minor of no change in clinical symptoms and physical findings associated with IFD); Progression (if worsening or new clinical symptoms and physical findings associated with IFD, or if alternative systemic antifungal treatment is required)
Not Evaluable: If not assessed or no clinical signs or symptoms at baseline
No assessment: Those participants that do not fall under any of the above criteria
Percentage of Participants With Clinical Response: Investigator Assessment
Investigator-assessed Clinical Response was defined as follows:
Success: if resolution of all attributable signs and symptoms or resolution of attributable clinical symptoms and physical findings
Failure: if no resolution of any attributable signs and symptoms or no resolution of any attributable signs and symptoms (no change) or worsening of any attributable signs and symptoms
Not Evaluable: if results not available /participant unevaluable or if no attributable signs and symptoms
No assessment: Those participants that do not fall under any of the above criteria
Percentage of Participants With Radiological Response: AC Assessment
AC-assessed Radiological Response was defined as follows:
Success: Complete (if ≥ 90% improvement); Partial (if at least < 25% response at day 42 and at least 50% response by Day 84)
Failure: Stable (if minor or no change in radiographic abnormalities associated with IFD, but no signs of progression); Progression (if worsening or new radiological abnormalities associated with IRD)
Not Evaluable: if no post baseline radiology available with baseline evidence of radiolical disease Or Radiology not applicable at baseline
No assessment: Those participants that do not fall under any of the above criteria
Percentage of Participants With Radiological Response: Investigator Assessment
Investigator's assessed radiological response was defined as follows:
Success: if ≥ 90% improvement, ≥ 50% to < 90% improvement, ≥ 25% to 50% improvement (for Day 42 only)
Failure if < 25% improvement at any time or no signs or radiological Images
Not Evaluable if results not evaluable or no radiological data available
No assessment: Those participants that do not fall under any of the above criteria
Percentage of Participants With Mycological Response: AC Assessment
AC assessed mycological response was defined as follows:
Success: Eradicated (no growth of the original [at baseline] causative organism on culture or identified by histology/cytology on post baseline [after day 7] cultures and/or histology/cytology); Presumed Eradicated (missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding)
Failure: Persistence (persistence of the original causative organism cultured or identified by histological /cytology at baseline); Presumed Persistence (missing post baseline documentation of the persistence of the original causative organism at baseline PLUS no resolution or worsening of any clinical symptoms/physical findings)
Not Evaluable - no mycological evidence
No assessment: Those participants that do not fall under any of the above criteria
Percentage of Participats With Mycological Response: Investigator Assessment
Investigator's assessed mycological response was defined as follows:
Success: Eradicated (no growth of the original [at baseline] causative organism on culture or identified by histology/cytology on post baseline [after day 7] cultures and/or histology/cytology); Presumed Eradicated (missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding)
Failure: Persistence (persistence of the original causative organism cultured or identified by histological /cytology at baseline); Presumed Persistence (missing post baseline documentation of the persistence of the original causative organism at baseline PLUS no resolution or worsening of any clinical symptoms/physical findings)
Not Evaluable: Indeterminate/no mycological follow-up or results available
No assessment: Those participants that do not fall under any of the above criteria
Pharmacokinetics of Isavuconazonium Sulphate in Plasma: Trough Concentration (Ctrough)
Ctrough was defined as the predose concentration at the end of dosing interval.
Full Information
NCT ID
NCT03816176
First Posted
January 23, 2019
Last Updated
August 24, 2023
Sponsor
Astellas Pharma Global Development, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03816176
Brief Title
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
Official Title
A Phase 2, Open-Label, Non-Comparative, Multicenter Study to Evaluate the Safety and Tolerability, Efficacy and Pharmacokinetics of Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Global Development, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.
Detailed Description
Treatment began on Day 1 and then participants were followed for 60 days post-last dose for safety. Treatment was administered until the participant had a successful outcome or for a maximum duration of 84 days (IA) or 180 days (IM), whichever occured first.
Participants received a loading regimen of isavuconazonium sulfate (via intravenous or oral administration at the investigator's discretion), which consisted of a dose every 8 hours (± 2 hours) on Days 1 and 2 (for a total of 6 doses), followed by once daily maintenance dosing for up to 84 days (IA) or 180 days (IM) of dosing. The first maintenance dose started 12 to 24 hours after the administration of the last loading dose. Subsequent maintenance doses were administered once daily (24 hours ± 2 hours from the previous maintenance dose). The oral formulation could only be given to participants 6 years to < 18 years of age and with a body weight of at least 12 kg. Participants who were discharged from the hospital with oral capsules for at-home administration had to return weekly for study drug accountability and to receive new oral dosing supplies. Participants who began oral administration were to complete the oral dosing acceptability assessment after ingesting their first oral dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Mucormycosis, Invasive Aspergillosis
Keywords
ASP9766, Cresemba, BAL8557, isavuconazonium sulfate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isavuconazonium sulfate
Arm Type
Experimental
Arm Description
Participants received 10 milligrams/killograms (mg/kg) dose of isavuconazonium sulfate every 8 hours (± 2 hours) on days 1 and 2 for a total of 6 doses (via intravenous or oral administration at the investigator's discretion) followed by once-daily maintenance dose of 10 mg/kg for up to 84 days IA or 180 days IM or until the participant had a successful outcome as judged by the investigator, whichever occured first. The route of administration could have been changed per the investigator's discretion.
Intervention Type
Drug
Intervention Name(s)
Isavuconazonium sulfate
Other Intervention Name(s)
Cresemba
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Isavuconazonium sulfate
Other Intervention Name(s)
Cresemba
Intervention Description
Oral capsule
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
An AE is any untoward medical occurrence in a participant administered a study drug, which does not have to have a causal relationship with this treatment. It can be any unfavorable sign, symptom, or disease temporally associated with the use of a medicinal product.
TEAE is defined as an AE observed after starting administration of the study drug through 30 days after the last dose.
Time Frame
From first dose to 30 days after the last dose (maximum 210 Days)
Title
Percentage of Participants With All - Cause Mortality Through Day 42
Description
All - Cause Mortality Through Day 42
Time Frame
Baseline up to 42 days
Secondary Outcome Measure Information:
Title
Percentage of Participants With All - Cause Mortality
Description
EOT was defined as anytime from "day 1 to a maximum of day 180". Data reported in the table below for each category, i.e., Day 84 represented data between Day 1 and Day 84 and for EOT, data represented between Day 1 to the EOT day for each individual. Participants who died after EOT assessment but before reaching Day 84 were included in the data for Day 84 category. Only those deaths that occurred after Day 84 would be included in EOT category if the death occurred during the treatment period (i.e. prior to the EOT).
Time Frame
Baseline up to day 84 and end of treatment (EOT) (up to a maximum of 180 days) (Average duration of treatment: 57.7 days)
Title
Percentage of Participants With Overall Response: Adjudication Committee (AC) Assessment
Description
Overall response was based on a composite of clinical, mycological, and radiological responses with success criteria assessed. Success criteria as assessed by AC in:
Clinical response:
Complete: Resolution of all attributable clinical symptoms and physical findings
Partial: Resolution of at Least some of the clinical symptoms and physical findings associated with IFD
Mycological response:
Eradication: No growth of the original (at baseline) causative organism on culture or identified by histology/cytology on post baseline (after day 7) cultures and/or histology/cytology
Presumed eradication: Missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding
Radiological response:
Complete: ≥ 90% improvement
Partial: At least < 25% response at day 42 and at least 50% by Day 84
Time Frame
Baseline up to days 42, 84 and EOT (180 days)
Title
Percentage of Participants With Clinical Response: AC Assessment
Description
AC Assessed Clinical response was defined as follows:
Success: Complete (if resolution of all attributable clinical symptoms and physical findings occurs); Partial (if resolution of at least some of the clinical symptoms and physical findings associated with IFD)
Failure: Stable (if minor of no change in clinical symptoms and physical findings associated with IFD); Progression (if worsening or new clinical symptoms and physical findings associated with IFD, or if alternative systemic antifungal treatment is required)
Not Evaluable: If not assessed or no clinical signs or symptoms at baseline
No assessment: Those participants that do not fall under any of the above criteria
Time Frame
Baseline up to days 42, 84 and EOT (180 days)
Title
Percentage of Participants With Clinical Response: Investigator Assessment
Description
Investigator-assessed Clinical Response was defined as follows:
Success: if resolution of all attributable signs and symptoms or resolution of attributable clinical symptoms and physical findings
Failure: if no resolution of any attributable signs and symptoms or no resolution of any attributable signs and symptoms (no change) or worsening of any attributable signs and symptoms
Not Evaluable: if results not available /participant unevaluable or if no attributable signs and symptoms
No assessment: Those participants that do not fall under any of the above criteria
Time Frame
Baseline up to days 42, 84 and EOT (180 days)
Title
Percentage of Participants With Radiological Response: AC Assessment
Description
AC-assessed Radiological Response was defined as follows:
Success: Complete (if ≥ 90% improvement); Partial (if at least < 25% response at day 42 and at least 50% response by Day 84)
Failure: Stable (if minor or no change in radiographic abnormalities associated with IFD, but no signs of progression); Progression (if worsening or new radiological abnormalities associated with IRD)
Not Evaluable: if no post baseline radiology available with baseline evidence of radiolical disease Or Radiology not applicable at baseline
No assessment: Those participants that do not fall under any of the above criteria
Time Frame
Baseline up to days 42, 84 and EOT (180 days)
Title
Percentage of Participants With Radiological Response: Investigator Assessment
Description
Investigator's assessed radiological response was defined as follows:
Success: if ≥ 90% improvement, ≥ 50% to < 90% improvement, ≥ 25% to 50% improvement (for Day 42 only)
Failure if < 25% improvement at any time or no signs or radiological Images
Not Evaluable if results not evaluable or no radiological data available
No assessment: Those participants that do not fall under any of the above criteria
Time Frame
Baseline up to days 42, 84 and EOT (180 days)
Title
Percentage of Participants With Mycological Response: AC Assessment
Description
AC assessed mycological response was defined as follows:
Success: Eradicated (no growth of the original [at baseline] causative organism on culture or identified by histology/cytology on post baseline [after day 7] cultures and/or histology/cytology); Presumed Eradicated (missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding)
Failure: Persistence (persistence of the original causative organism cultured or identified by histological /cytology at baseline); Presumed Persistence (missing post baseline documentation of the persistence of the original causative organism at baseline PLUS no resolution or worsening of any clinical symptoms/physical findings)
Not Evaluable - no mycological evidence
No assessment: Those participants that do not fall under any of the above criteria
Time Frame
Baseline up to days 42, 84 and EOT (180 days)
Title
Percentage of Participats With Mycological Response: Investigator Assessment
Description
Investigator's assessed mycological response was defined as follows:
Success: Eradicated (no growth of the original [at baseline] causative organism on culture or identified by histology/cytology on post baseline [after day 7] cultures and/or histology/cytology); Presumed Eradicated (missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding)
Failure: Persistence (persistence of the original causative organism cultured or identified by histological /cytology at baseline); Presumed Persistence (missing post baseline documentation of the persistence of the original causative organism at baseline PLUS no resolution or worsening of any clinical symptoms/physical findings)
Not Evaluable: Indeterminate/no mycological follow-up or results available
No assessment: Those participants that do not fall under any of the above criteria
Time Frame
Baseline up to days 42, 84 and EOT (180 days)
Title
Pharmacokinetics of Isavuconazonium Sulphate in Plasma: Trough Concentration (Ctrough)
Description
Ctrough was defined as the predose concentration at the end of dosing interval.
Time Frame
Predose on days 7, and 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject diagnosed with IA or IM. A positive diagnosis is defined as follows:
Proven, probable or possible IFI per the European Organisation for Research and Treatment of Cancer/Mycoses Study Group [EORTC/MSG], 2008 criteria Note: Subjects with "possible" IFI will be eligible for enrollment; however, diagnostic tests to confirm the invasive fungal disease as "probable" or "proven" according to the EORTC/MSG criteria should be completed within 10 calendar days after the first dose of study drug
Note: In addition to the criteria set for mycological criteria by the EORTC/MSG in 2008, and only for subjects with an underlying hematologic malignancy or recipients of hematopoietic stem cell transplant (HSCT) who also have clinical and radiologic features consistent with invasive fungal infection, the following are acceptable:
Galactomannan (GM) levels (optical density index) meeting the below criteria are acceptable mycological evidence for enrollment or upgrading the diagnosis to probable IA:
1. A single value for serum or bronchoalveolar lavage (BAL) fluid of ≥ 1.0 or
2. Two serum GM values of ≥ 0.5 from two separate samples
Subject has sufficient venous access to permit intravenous administration of study drug or the ability to swallow oral capsules
A female subject is eligible to participate if not pregnant and at least one of the following conditions applies:
Not a subject who is of childbearing potential, OR
Subject who is of childbearing potential who agrees to follow a contraceptive guidance throughout the treatment period and for at least 30 days after the final study drug administration
Subject and subject's parent(s) or legal guardian agree that the subject will not participate in another interventional study while on treatment with the exception of oncology trials
Exclusion Criteria:
Subject has familial short QT syndrome, is receiving medications that are known to shorten the QT interval, or has a clinically significant abnormal ECG
Subject has evidence of hepatic dysfunction defined as any of the following:
Total bilirubin (TBL) ≥ 3 times the upper limit of normal (ULN)
Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 5 times the ULN
Known cirrhosis or chronic hepatic failure
Subject has used strong cytochrome P450 (CYP3A4) inhibitors or inducers such as ketoconazole, high dose ritonavir, rifampin/rifampicin, long acting barbiturates (e.g., phenytoin), carbamazepine and St. John's Wort in the 5 days prior to the first dose of study drug
Subject has another IFI other than possible, probably or proven IA or IM
Subject has chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis
Subject has received mould active systemic antifungal therapy, effective against the primary IMI, for more than four days during the seven days preceding the first dose
Note: Prior use of prophylactic antifungal therapy is acceptable. In case of breakthrough IA while on prophylactic mould-active azole class drugs, additional documentation will be required to be submitted to the sponsor medical monitor or designee to approve subject enrollment
Subject has known history of allergy, hypersensitivity or any serious reaction to any of the azole class antifungals, or any components of the study drug formulation
Subject has any condition which makes the subject unsuitable for study participation
Subject is unlikely to survive 30 days
Subject has received investigational drug, with the exception of oncology drug trials, or trials with investigational drugs treating graft versus host disease, within 28 days or five half-lives, whichever is longer, prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Executive Director
Organizational Affiliation
Astellas Pharma Global Development, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
University of California - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Site BE32001
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Site BE32002
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Site ES34002
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Site ES34003
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Site ES34001
City
Madrid
ZIP/Postal Code
28041
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Learn more about this trial
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
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