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FASENRA SCEI for Long-term Use

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03588546
Collaborator
(none)
780
Enrollment
39
Locations
83
Anticipated Duration (Months)
20
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the investigation is to confirm the safety and efficacy under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.

    1. Detection of unexpected Adverse Drug Reactions

    2. To grasp development of Adverse Drug Reactions

    3. To grasp contributing factors possibly having an impact on the safety and efficacy

    4. Development of key investigational safety specification (serious infection).

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    780 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    FASENRA Subcutaneous Injection 30 mg Syringe Specific Clinical Experience Investigation for Long-term Use
    Actual Study Start Date :
    May 31, 2018
    Anticipated Primary Completion Date :
    Apr 30, 2025
    Anticipated Study Completion Date :
    Apr 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Incidences of adverse drug reactions (ADRs) [all ADRS, unexpected ADRs and key investigational safety specification (serious infection)] [1 year]

    Secondary Outcome Measures

    1. Change scores from baseline in Asthma Control Questionnaire (ACQ) with exploring a factor to affect them by patient's background and treatment condition [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    -The evaluable patients treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy).

    Exclusion Criteria:

    -No past history of hypersensitivity to the components of Fasenra.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Aichi Japan D3250C00057
    2 Research Site Akita Japan D3250C00057
    3 Research Site Aomori Japan D3250C00057
    4 Research Site Chiba Japan D3250C00057
    5 Research Site Ehime Japan D3250C00057
    6 Research Site Fukui Japan D3250C00057
    7 Research Site Fukuoka Japan D3250C00057
    8 Research Site Fukushima Japan D3250C00057
    9 Research Site Gifu Japan D3250C00057
    10 Research Site Gunma Japan D3250C00057
    11 Research Site Hiroshima Japan D3250C00057
    12 Research Site Hokkaido Japan D3250C00057
    13 Research Site Hyogo Japan D3250C00057
    14 Research Site Ibaraki Japan D3250C00057
    15 Research Site Iwate Japan D3250C00057
    16 Research Site Kagawa Japan D3250C00057
    17 Research Site Kagoshima Japan D3250C00057
    18 Research Site Kanagawa Japan D3250C00057
    19 Research Site Kochi Japan D3250C00057
    20 Research Site Kumamoto Japan D3250C00057
    21 Research Site Kyoto Japan D3250C00057
    22 Research Site Mie Japan D3250C00057
    23 Research Site Miyagi Japan D3250C00057
    24 Research Site Nagano Japan D3250C00057
    25 Research Site Nara Japan D3250C00057
    26 Research Site Niigata Japan D3250C00057
    27 Research Site Oita Japan D3250C00057
    28 Research Site Okayama Japan D3250C00057
    29 Research Site Okinawa Japan D3250C00057
    30 Research Site Osaka Japan D3250C00057
    31 Research Site Saitama Japan D3250C00057
    32 Research Site Shiga Japan D3250C00057
    33 Research Site Shizuoka Japan D3250C00057
    34 Research Site Tochigi Japan D3250C00057
    35 Research Site Tokyo Japan D3250C00057
    36 Research Site Tottori Japan D3250C00057
    37 Research Site Toyama Japan D3250C00057
    38 Research Site Yamagata Japan D3250C00057
    39 Research Site Yamaguchi Japan D3250C00057

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Toshimitsu Tokimoto, AstraZeneca KK

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT03588546
    Other Study ID Numbers:
    • D3250C00057
    First Posted:
    Jul 17, 2018
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jul 1, 2022
    Keywords provided by AstraZeneca
    Fasenra Benralizumab Bronchial asthma
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Jul 6, 2022