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Astellas Study ID
9766-CL-0107

A study to evaluate isavuconazonium sulfate for the treatment of invasive aspergillosis (IA) or invasive mucormycosis (IM) in pediatric participants

Astellas Study ID
9766-CL-0107
Clinicaltrials.gov ID
NCT03816176
EUCTIS ID
N/A
EudraCT ID
2018-003975-36
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.

Additional Study Details

Phase
Phase 2
Product
N/A
Product
  • Isavuconazonium sulfate
    • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    30
    Show Additional Study Details

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    Would you like more information about clinical trial sites that are recruiting participants for A study to evaluate isavuconazonium sulfate for the treatment of invasive aspergillosis (IA) or invasive mucormycosis (IM) in pediatric participants? Contact us by filling out your information to the right and we’ll respond to you.

    • A caregiver
    • A healthcare provider
    • A parent
    • A patient
    • A patient advocate
    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
    • Italy
    • Japan
    • Jordan
    • Kazakhstan
    • Latvia
    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
    • Mexico
    • Montenegro
    • Morocco
    • Netherlands
    • New Zealand
    • Norway
    • Panama
    • Peru
    • Philippines
    • Poland
    • Portugal
    • Puerto Rico
    • Republic of Korea
    • Republic of Moldova
    • Romania
    • Russian Federation
    • Saudi Arabia
    • Serbia
    • Singapore
    • Slovakia
    • Slovenia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

    By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

      Locations

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      Recruiting
      Site ES34003
      Madrid, Spain, 28009
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      Recruiting
      St Jude Children's Res Hospital
      Memphis, TN, United States, 38105
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      Recruiting
      Children's Mercy Hospital
      Kansas City, Mo, United States, 64108
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      Recruiting
      Site BE32002
      Leuven, Belgium, 3000
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      Recruiting
      Children's National Medical Center
      Washington, DC, United States, 20010
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      Recruiting
      University of California - Los Angeles
      Los Angeles, CA, United States, 90095
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      Recruiting
      Nicklaus Children's Hospital
      Miami, FL, United States, 33155
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      Recruiting
      Ann & Robert H. Lurie Children's Hospital of Chicago
      Chicago, IL, United States, 60611
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      Recruiting
      Children's Hospital of Orange County
      Orange, CA, United States, 92868
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      Recruiting
      Miller Children's Hospital
      Long Beach, CA, United States, 90806
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      Recruiting
      SUNY Upstate Medical University
      Syracuse, NY, United States, 13210
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      Recruiting
      Site ES34001
      Madrid, Spain, 28041
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      Recruiting
      Site EU49001
      Munster, Germany, 48149
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      Recruiting
      Site BE32001
      Gent, Belgium, 9000
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      Recruiting
      University of Louisville
      Louisville, KY, United States, 40202
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      Recruiting
      Site EU34002
      Barcelona, Spain, 8035
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      Recruiting
      Cincinnati Children's Hospital
      Cincinnati, OH, United States, 45229
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      Recruiting
      Children's Hospital, Los Angeles
      Los Angeles, CA, United States, 90027
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      Recruiting
      Children's Hospital, LSUHSC, New Orleans
      New Orleans, LA, United States, 70118
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      Recruiting
      University Children's Hospital Essen
      Essen, Nordrhein-Westfalen, Germany, 45147
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      Trial info
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      Age
      1 - 17 years
      Diamond icon
      Condition
    • Fungal Infections
      • Gender icon
      Sex
      Female & Male
      Calendar icon
      Trial Dates
      Aug 2019 - Apr 2023
      Additional Study Details
      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

      MaximizeExclusion 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

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