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Clinical trials for Baloxavir Marboxil

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   43881   clinical trials with a EudraCT protocol, of which   7295   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    7 result(s) found for: Baloxavir Marboxil. Displaying page 1 of 1.
    EudraCT Number: 2020-000696-20 Sponsor Protocol Number: 1719T0834 Start Date*: 2020-03-31
    Sponsor Name:Shionogi & Co., Ltd.
    Full Title: A phase 3 randomized, double-blind, placebo-controlled study to confirm the efficacy of a single dose of baloxavir marboxil in the prevention of influenza virus infection
    Medical condition: Influenza
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-002169-21 Sponsor Protocol Number: CP40563 Start Date*: 2018-11-19
    Sponsor Name:Roche Farma SA que realiza un el ensayo en España y que actúa como representante de F. Hoffmann-La Roche Ltd
    Full Title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE (OSELTAMIVIR)-CONTROLLED STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF BALOXAVIR MARBOXIL IN OTHERWISE HEALTHY PEDIATRIC PATIENTS 1 T...
    Medical condition: Influenza
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10022001 Influenza (epidemic) LLT
    20.1 100000004862 10022003 Influenza B virus infection LLT
    20.1 100000004862 10022002 Influenza A virus infection LLT
    20.0 100000004862 10016790 Flu LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-001416-30 Sponsor Protocol Number: CP40617 Start Date*: 2018-12-12
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BALOXAVIR MARBOXIL IN COMBINATION WITH STANDARD-OF-CARE NEURAMINIDASE INHIBITOR IN...
    Medical condition: INFLUENZA
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10016790 Flu LLT
    20.0 100000004862 10022001 Influenza (epidemic) LLT
    20.1 100000004862 10022003 Influenza B virus infection LLT
    20.1 100000004862 10022002 Influenza A virus infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) EE (Completed) CZ (Completed) SE (Completed) BE (Completed) DE (Completed) FR (Completed) FI (Completed) HU (Completed) ES (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2021-001026-22 Sponsor Protocol Number: 1813T0835 Start Date*: 2021-03-05
    Sponsor Name:Shionogi & Co., Ltd.
    Full Title: An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Baloxavir Marboxil 2% Granules after Administration of a Single Dose to Otherwise Healthy Pediatric Patient...
    Medical condition: Influenza
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-002154-70 Sponsor Protocol Number: CP40559 Start Date*: 2019-10-24
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF BALOXAVIR MARBOXIL IN OTHERWISE HEALTHY PEDIATRIC PATIENTS FROM BIRTH TO LESS THAN 1 YEAR WITH IN...
    Medical condition: Influenza
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10022001 Influenza (epidemic) LLT
    20.1 100000004862 10022003 Influenza B virus infection LLT
    20.1 100000004862 10022002 Influenza A virus infection LLT
    20.0 100000004862 10016790 Flu LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed) ES (Ongoing) FI (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2018-004056-37 Sponsor Protocol Number: MV40618 Start Date*: 2019-10-17
    Sponsor Name:Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    Full Title: A PHASE IIIB, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, CLINICAL EFFICACY STUDY OF BALOXAVIR MARBOXIL FOR THE REDUCTION OF DIRECT TRANSMISSION OF INFLUENZA FROM OTHERWISE HEALTHY P...
    Medical condition: Influenza
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10022001 Influenza (epidemic) LLT
    20.1 100000004862 10022003 Influenza B virus infection LLT
    20.1 100000004862 10022002 Influenza A virus infection LLT
    20.0 100000004862 10016790 Flu LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Temporarily Halted) GB (GB - no longer in EU/EEA) GR (Completed) HU (Ongoing) PL (Ongoing) FR (Completed) BG (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002340-14 Sponsor Protocol Number: REMAP-CAP Start Date*: 2015-09-16
    Sponsor Name:University Medical Center Utrecht
    Full Title: Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP). (COVID-19)
    Medical condition: Severe Community Acquired Pneumonia COVID-19
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10010120 Community acquired pneumonia LLT
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) IE (Trial now transitioned) PT (Trial now transitioned) GB (GB - no longer in EU/EEA) HU (Ongoing) BE (Trial now transitioned) DE (Ongoing) HR (Ongoing) ES (Temporarily Halted) FR (Trial now transitioned) FI (Ongoing) IT (Ongoing) CZ (Trial now transitioned) SI (Ongoing) RO (Ongoing)
    Trial results: (No results available)
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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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