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Clinical trials for Isavuconazonium

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    7 result(s) found for: Isavuconazonium. Displaying page 1 of 1.
    EudraCT Number: 2018-003975-36 Sponsor Protocol Number: 9766-CL-0107 Start Date*: 2019-12-13
    Sponsor Name:Astellas Pharma Global Development, Inc.
    Full 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 Aspergillos...
    Medical condition: Invasive Aspergillosis and Invasive Mucormycosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10062642 Invasive mycosis LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) DE (Completed) ES (Ongoing) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-004930-41 Sponsor Protocol Number: 9766-CL-0046 Start Date*: 2020-01-22
    Sponsor Name:Astellas Pharma Global Development, Inc.
    Full Title: A Phase 1, Open-Label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
    Medical condition: This is a phase I pharmacokinetic study and does not investigate a medical condition
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-005294-30 Sponsor Protocol Number: WSA-CS-002 Start Date*: 2006-05-10
    Sponsor Name:Basilea Pharmaceutica Ltd.
    Full Title: Open-label, multi-center, sequential group, clinical study to determine the safety and efficacy of escalating dosing regimens of intravenous or oral BAL8557 in the prophylaxis of patients undergoin...
    Medical condition: Neutropenic patients over 18 years with acute myeloid leukemia (AML).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-005003-33 Sponsor Protocol Number: WSA-CS-003 Start Date*: 2008-06-26
    Sponsor Name:Astellas Global Pharma Development, Inc
    Full Title: Open label study of isavuconazole in the treatment of patients with aspergillosis and renal impairment or of patients with invasive fungal disease caused by rare moulds, yeasts or dimorphic fungi.
    Medical condition: Invasive fungal disease caused by Aspergillus species in patients with renal impairment as well as disease caused by rare moulds, yeasts or dimorphic fungi.
    Disease: Version SOC Term Classification Code Term Level
    15.0 10021881 - Infections and infestations 10003486 Aspergillus infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) HU (Completed) CZ (Prematurely Ended) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2006-003951-18 Sponsor Protocol Number: WSA-CS-008 Start Date*: 2007-05-29
    Sponsor Name:Astellas Global Pharma Development, Inc.
    Full Title: A phase III, double-blind, randomized study to evaluate the safety and efficacy of BAL8557 versus a Caspofungin followed by Voriconazole regimen in the treatment of candidemia and other invasive Ca...
    Medical condition: Treatment of Candidemia and other invasive Candida infections
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004862 10060573 Candidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) HU (Completed) ES (Completed) NL (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-003868-59 Sponsor Protocol Number: WSA-CS-004 Start Date*: 2011-05-12
    Sponsor Name:Astellas Global Pharma Development, Inc.
    Full 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 Apsergillus species or other fi...
    Medical condition: Invasive fungal disease caused by Aspergillus species or other filamentous fungi.
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10003488 Aspergillosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) HU (Completed) ES (Completed) NL (Completed) IT (Completed) GB (Completed) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003921-40 Sponsor Protocol Number: 2016IF002 Start Date*: 2017-07-21
    Sponsor Name:University Hospital of South Manchester NHS Foundation Trust
    Full Title: Open label study of the efficacy and safety of isavuconazole for the treatment of Chronic Pulmonary Aspergillosis
    Medical condition: Chronic Pulmonary Aspergillosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000154164 10003488 Aspergillosis LLT
    20.0 100000015649 10003493 Aspergillus fumigatus bronchopulmonary infection LLT
    20.0 100000154164 10003494 Aspergillus fumigatus infection LLT
    20.0 10021881 - Infections and infestations 10006473 Bronchopulmonary aspergillosis PT
    20.0 100000015649 10059259 Pulmonary aspergillosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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