<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03816176</url>
  </required_header>
  <id_info>
    <org_study_id>9766-CL-0107</org_study_id>
    <secondary_id>2018-003975-36</secondary_id>
    <nct_id>NCT03816176</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety, tolerability, and efficacy of&#xD;
      isavuconazonium sulfate in pediatric participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment will begin on Day 1 and then participants will be followed for 60 days post-last&#xD;
      dose for safety. Treatment will be administered until the participant has a successful&#xD;
      outcome or for a maximum duration of 84 days (IA) or 180 days (IM), whichever occurs first.&#xD;
&#xD;
      Participants will receive a loading regimen of isavuconazonium sulfate (via intravenous or&#xD;
      oral administration at the investigator's discretion), which consists of a dose every 8 hours&#xD;
      (± 2 hours) on Days 1 and 2 (for a total of 6 doses), followed by once daily maintenance&#xD;
      dosing for up to 84 days (IA) or 180 days (IM) of dosing. The first maintenance dose should&#xD;
      start 12 to 24 hours after the administration of the last loading dose. Subsequent&#xD;
      maintenance doses will be administered once daily (24 hours ± 2 hours from the previous&#xD;
      maintenance dose). The oral formulation can only be given to subjects 6 years to &lt; 18 years&#xD;
      of age and with a body weight of at least 12 kg. Subjects who are discharged from the&#xD;
      hospital with oral capsules for at-home administration must return weekly for study drug&#xD;
      accountability and to receive new oral dosing supplies. Subjects who begin oral&#xD;
      administration are to complete the oral dosing acceptability assessment after ingesting their&#xD;
      first oral dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2019</start_date>
  <completion_date type="Actual">December 14, 2022</completion_date>
  <primary_completion_date type="Actual">December 14, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety assessed by Adverse Events (AEs)</measure>
    <time_frame>Up to 240 days</time_frame>
    <description>An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with vital sign abnormalities and /or adverse events</measure>
    <time_frame>Up to 84 days</time_frame>
    <description>Number of participants with potentially clinically significant vital sign values</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety assessed by 12- lead electrocardiogram (ECG)</measure>
    <time_frame>Up to 84 days</time_frame>
    <description>A 12-lead, resting ECG will be recorded after participant has remained supine for at least 5 minutes. The results (normal, abnormal not clinically significant, abnormal clinically significant) are to be recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with laboratory value abnormalities and/or adverse events (AEs)</measure>
    <time_frame>Up to 84 days</time_frame>
    <description>Number of participants with potentially clinically significant laboratory values</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All-cause mortality through Day 42</measure>
    <time_frame>Up to 42 days</time_frame>
    <description>Each participant will be classified as either a death or alive</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality through Day 84</measure>
    <time_frame>Up to 84 days</time_frame>
    <description>Each participant will be classified as either a death or alive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality at End of Treatment (EOT)</measure>
    <time_frame>Up to 180 days</time_frame>
    <description>Each participant will be classified as either a death or alive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response through Day 42</measure>
    <time_frame>Up to 42 days</time_frame>
    <description>Overall response through day 42 will be based on clinical, mycological, and radiological response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response through Day 84</measure>
    <time_frame>Up to 84 days</time_frame>
    <description>Overall response through day 84 will be based on clinical, mycological, and radiological response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response at EOT</measure>
    <time_frame>Up to 180 days</time_frame>
    <description>Overall response through EOT will be based on clinical, mycological, and radiological response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response through Day 42</measure>
    <time_frame>Up to 42 days</time_frame>
    <description>Each participant will be assessed for changes in clinical sign and symptoms of infection(s)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response through Day 84</measure>
    <time_frame>Up to 84 days</time_frame>
    <description>Each participant will be assessed for changes in clinical sign and symptoms of infection(s)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response at EOT</measure>
    <time_frame>Up to 180 days</time_frame>
    <description>Each participant will be assessed for changes in clinical sign and symptoms of infection(s)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological response through Day 42</measure>
    <time_frame>Up to 42 days</time_frame>
    <description>Each participant will be assessed for radiological evidence of fungal disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological response through Day 84</measure>
    <time_frame>Up to 84 days</time_frame>
    <description>Each participant will be assessed for radiological evidence of fungal disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological response at EOT</measure>
    <time_frame>Up to 180 days</time_frame>
    <description>Each participant will be assessed for radiological evidence of fungal disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mycological response through Day 42</measure>
    <time_frame>Up to 42 days</time_frame>
    <description>Each participant will be assessed for mycological evidence of fungal disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mycological response through Day 84</measure>
    <time_frame>Up to 84 days</time_frame>
    <description>Each participant will be assessed for mycological evidence of fungal disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mycological response at EOT</measure>
    <time_frame>Up to 180 days</time_frame>
    <description>Each participant will be assessed for mycological evidence of fungal disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of isavuconazole in plasma: trough concentration (Ctrough)</measure>
    <time_frame>Up to 84 days</time_frame>
    <description>Ctrough will be recorded from the pharmacokinetic (PK) plasma samples collected</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Invasive Mucormycosis</condition>
  <condition>Invasive Aspergillosis</condition>
  <arm_group>
    <arm_group_label>Isavuconazonium sulfate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a loading dose of isavuconazonium sulfate (via intravenous or oral administration at the investigator's discretion) every 8 hours (± 2 hours) on Days 1 and 2 followed by once-daily maintenance dosing</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isavuconazonium sulfate</intervention_name>
    <description>Intravenous (IV) infusion</description>
    <arm_group_label>Isavuconazonium sulfate</arm_group_label>
    <other_name>Cresemba</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isavuconazonium sulfate</intervention_name>
    <description>Oral capsule</description>
    <arm_group_label>Isavuconazonium sulfate</arm_group_label>
    <other_name>Cresemba</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject diagnosed with IA or IM. A positive diagnosis is defined as follows:&#xD;
&#xD;
               -  Proven, probable or possible IFI per the European Organisation for Research and&#xD;
                  Treatment of Cancer/Mycoses Study Group [EORTC/MSG], 2008 criteria Note: Subjects&#xD;
                  with &quot;possible&quot; IFI will be eligible for enrollment; however, diagnostic tests to&#xD;
                  confirm the invasive fungal disease as &quot;probable&quot; or &quot;proven&quot; according to the&#xD;
                  EORTC/MSG criteria should be completed within 10 calendar days after the first&#xD;
                  dose of study drug&#xD;
&#xD;
               -  Note: In addition to the criteria set for mycological criteria by the EORTC/MSG&#xD;
                  in 2008, and only for subjects with an underlying hematologic malignancy or&#xD;
                  recipients of hematopoietic stem cell transplant (HSCT) who also have clinical&#xD;
                  and radiologic features consistent with invasive fungal infection, the following&#xD;
                  are acceptable:&#xD;
&#xD;
               -  Galactomannan (GM) levels (optical density index) meeting the below criteria are&#xD;
                  acceptable mycological evidence for enrollment or upgrading the diagnosis to&#xD;
                  probable IA:&#xD;
&#xD;
               -  1. A single value for serum or bronchoalveolar lavage (BAL) fluid of ≥ 1.0 or&#xD;
&#xD;
               -  2. Two serum GM values of ≥ 0.5 from two separate samples&#xD;
&#xD;
          -  Subject has sufficient venous access to permit intravenous administration of study&#xD;
             drug or the ability to swallow oral capsules&#xD;
&#xD;
          -  A female subject is eligible to participate if not pregnant and at least one of the&#xD;
             following conditions applies:&#xD;
&#xD;
               -  Not a subject who is of childbearing potential, OR&#xD;
&#xD;
               -  Subject who is of childbearing potential who agrees to follow a contraceptive&#xD;
                  guidance throughout the treatment period and for at least 30 days after the final&#xD;
                  study drug administration&#xD;
&#xD;
          -  Subject and subject's parent(s) or legal guardian agree that the subject will not&#xD;
             participate in another interventional study while on treatment with the exception of&#xD;
             oncology trials&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has familial short QT syndrome, is receiving medications that are known to&#xD;
             shorten the QT interval, or has a clinically significant abnormal ECG&#xD;
&#xD;
          -  Subject has evidence of hepatic dysfunction defined as any of the following:&#xD;
&#xD;
               -  Total bilirubin (TBL) ≥ 3 times the upper limit of normal (ULN)&#xD;
&#xD;
               -  Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 5 times the ULN&#xD;
&#xD;
               -  Known cirrhosis or chronic hepatic failure&#xD;
&#xD;
          -  Subject has used strong cytochrome P450 (CYP3A4) inhibitors or inducers such as&#xD;
             ketoconazole, high dose ritonavir, rifampin/rifampicin, long acting barbiturates&#xD;
             (e.g., phenytoin), carbamazepine and St. John's Wort in the 5 days prior to the first&#xD;
             dose of study drug&#xD;
&#xD;
          -  Subject has another IFI other than possible, probably or proven IA or IM&#xD;
&#xD;
          -  Subject has chronic aspergillosis, aspergilloma or allergic bronchopulmonary&#xD;
             aspergillosis&#xD;
&#xD;
          -  Subject has received mould active systemic antifungal therapy, effective against the&#xD;
             primary IMI, for more than four days during the seven days preceding the first dose&#xD;
&#xD;
               -  Note: Prior use of prophylactic antifungal therapy is acceptable. In case of&#xD;
                  breakthrough IA while on prophylactic mould-active azole class drugs, additional&#xD;
                  documentation will be required to be submitted to the sponsor medical monitor or&#xD;
                  designee to approve subject enrollment&#xD;
&#xD;
          -  Subject has known history of allergy, hypersensitivity or any serious reaction to any&#xD;
             of the azole class antifungals, or any components of the study drug formulation&#xD;
&#xD;
          -  Subject has any condition which makes the subject unsuitable for study participation&#xD;
&#xD;
          -  Subject is unlikely to survive 30 days&#xD;
&#xD;
          -  Subject has received investigational drug, with the exception of oncology drug trials,&#xD;
             or trials with investigational drugs treating graft versus host disease, within 28&#xD;
             days or five half-lives, whichever is longer, prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Executive Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California - Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Orange County</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's National Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site BE32001</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site BE32002</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site ES34002</name>
      <address>
        <city>Barcelona</city>
        <zip>8035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site ES34003</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site ES34001</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 13, 2023</last_update_submitted>
  <last_update_submitted_qc>January 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ASP9766</keyword>
  <keyword>Cresemba</keyword>
  <keyword>BAL8557</keyword>
  <keyword>isavuconazonium sulfate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspergillosis</mesh_term>
    <mesh_term>Mucormycosis</mesh_term>
    <mesh_term>Zygomycosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Isavuconazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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 &quot;Sponsor Specific Details for Astellas.&quot;</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>May 31, 2023</submitted>
    <returned>June 23, 2023</returned>
    <submitted>July 14, 2023</submitted>
    <returned>August 1, 2023</returned>
    <submitted>August 24, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03816176
org study id: 9766-CL-0107
secondary id: 2018-003975-36
nct id: NCT03816176
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety, tolerability, and efficacy of
      isavuconazonium sulfate in pediatric participants.
Treatment will begin on Day 1 and then participants will be followed for 60 days post-last
      dose for safety. Treatment will be administered until the participant has a successful
      outcome or for a maximum duration of 84 days (IA) or 180 days (IM), whichever occurs first.

      Participants will receive a loading regimen of isavuconazonium sulfate (via intravenous or
      oral administration at the investigator's discretion), which consists 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 should
      start 12 to 24 hours after the administration of the last loading dose. Subsequent
      maintenance doses will be administered once daily (24 hours ± 2 hours from the previous
      maintenance dose). The oral formulation can only be given to subjects 6 years to < 18 years
      of age and with a body weight of at least 12 kg. Subjects who are discharged from the
      hospital with oral capsules for at-home administration must return weekly for study drug
      accountability and to receive new oral dosing supplies. Subjects who begin oral
      administration are to complete the oral dosing acceptability assessment after ingesting their
      first oral dose.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety assessed by Adverse Events (AEs)
time frame: Up to 240 days
description: An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
measure: Number of participants with vital sign abnormalities and /or adverse events
time frame: Up to 84 days
description: Number of participants with potentially clinically significant vital sign values
measure: Safety assessed by 12- lead electrocardiogram (ECG)
time frame: Up to 84 days
description: A 12-lead, resting ECG will be recorded after participant has remained supine for at least 5 minutes. The results (normal, abnormal not clinically significant, abnormal clinically significant) are to be recorded
measure: Number of participants with laboratory value abnormalities and/or adverse events (AEs)
time frame: Up to 84 days
description: Number of participants with potentially clinically significant laboratory values
measure: All-cause mortality through Day 42
time frame: Up to 42 days
description: Each participant will be classified as either a death or alive
measure: All-cause mortality through Day 84
time frame: Up to 84 days
description: Each participant will be classified as either a death or alive
measure: All-cause mortality at End of Treatment (EOT)
time frame: Up to 180 days
description: Each participant will be classified as either a death or alive
measure: Overall response through Day 42
time frame: Up to 42 days
description: Overall response through day 42 will be based on clinical, mycological, and radiological response
measure: Overall response through Day 84
time frame: Up to 84 days
description: Overall response through day 84 will be based on clinical, mycological, and radiological response
measure: Overall response at EOT
time frame: Up to 180 days
description: Overall response through EOT will be based on clinical, mycological, and radiological response
measure: Clinical response through Day 42
time frame: Up to 42 days
description: Each participant will be assessed for changes in clinical sign and symptoms of infection(s)
measure: Clinical response through Day 84
time frame: Up to 84 days
description: Each participant will be assessed for changes in clinical sign and symptoms of infection(s)
measure: Clinical response at EOT
time frame: Up to 180 days
description: Each participant will be assessed for changes in clinical sign and symptoms of infection(s)
measure: Radiological response through Day 42
time frame: Up to 42 days
description: Each participant will be assessed for radiological evidence of fungal disease
measure: Radiological response through Day 84
time frame: Up to 84 days
description: Each participant will be assessed for radiological evidence of fungal disease
measure: Radiological response at EOT
time frame: Up to 180 days
description: Each participant will be assessed for radiological evidence of fungal disease
measure: Mycological response through Day 42
time frame: Up to 42 days
description: Each participant will be assessed for mycological evidence of fungal disease
measure: Mycological response through Day 84
time frame: Up to 84 days
description: Each participant will be assessed for mycological evidence of fungal disease
measure: Mycological response at EOT
time frame: Up to 180 days
description: Each participant will be assessed for mycological evidence of fungal disease
measure: Pharmacokinetics of isavuconazole in plasma: trough concentration (Ctrough)
time frame: Up to 84 days
description: Ctrough will be recorded from the pharmacokinetic (PK) plasma samples collected
arm group label: Isavuconazonium sulfate
arm group type: Experimental
description: Participants will receive a loading dose of isavuconazonium sulfate (via intravenous or oral administration at the investigator's discretion) every 8 hours (± 2 hours) on Days 1 and 2 followed by once-daily maintenance dosing
intervention type: Drug
intervention name: Isavuconazonium sulfate
description: Intravenous (IV) infusion
arm group label: Isavuconazonium sulfate
other name: Cresemba
intervention type: Drug
intervention name: Isavuconazonium sulfate
description: Oral capsule
arm group label: Isavuconazonium sulfate
other name: Cresemba
criteria: 
gender: All
minimum age: 1 Year
maximum age: 17 Years
healthy volunteers: No
last name: Executive Director
role: Study Director
affiliation: Astellas Pharma Global Development, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Spain
country: United States
country: Germany
country: United Kingdom
responsible party type: Sponsor
mesh term: Aspergillosis
mesh term: Mucormycosis
mesh term: Zygomycosis
mesh term: Isavuconazole
sharing ipd: No
ipd 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."
submitted: May 31, 2023
returned: June 23, 2023
submitted: July 14, 2023
returned: August 1, 2023
submitted: August 24, 2023