NCT03588546|Completed
FASENRA SCEI for Long-term Use
FASENRA Subcutaneous Injection 30 mg Syringe Specific Clinical Experience Investigation for Long-term Use
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FASENRA Subcutaneous Injection 30 mg Syringe Specific Clinical Experience Investigation for Long-term Use
Sponsor study identifier
observational
653
1 country
29
Study Start
May 31, 2018
Actual (reported)Primary Completion
September 10, 2024
Actual (reported)Study Completion
September 10, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 10, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 25, 2018
Actual (reported)May 31, 2018
Actual (reported)July 17, 2018
Actual (reported)September 10, 2024
Actual (reported)September 10, 2024
Actual (reported)Incidences of adverse drug reactions (ADRs) [all ADRS, unexpected ADRs and key investigational safety specification (serious infection)]
1 year
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
The 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).
Research Site
Aichi, D3250C00057, Japan
Research Site
Akita, D3250C00057, Japan
Research Site
Aomori, D3250C00057, Japan
Research Site
Chiba, D3250C00057, Japan
Research Site
Ehime, D3250C00057, Japan
Research Site
Fukuoka, D3250C00057, Japan
Research Site
Gunma, D3250C00057, Japan
Toshimitsu Tokimoto
AstraZeneca KK
653 participants (actual enrollment reported by the registry).
First Submitted
May 25, 2018
First Posted
July 17, 2018
Study Start
May 31, 2018
Actual (reported)A Study to Evaluate the Pharmacokinetics of Tezepelumab After Being Delivered by an Accessorized Pre Filled Syringe or Autoinjector Compared With Vial and Syringe in Healthy Adult Subjects
Contact the study team to confirm eligibility.
Research Site
Hiroshima, D3250C00057, Japan
Research Site
Hokkaido, D3250C00057, Japan
Research Site
Hyōgo, D3250C00057, Japan
Research Site
Ibaraki, D3250C00057, Japan
Research Site
Kagawa, D3250C00057, Japan
Research Site
Kagoshima, D3250C00057, Japan
Research Site
Kanagawa, D3250C00057, Japan
Research Site
Kumamoto, D3250C00057, Japan
Research Site
Kyoto, D3250C00057, Japan
Research Site
Mie, D3250C00057, Japan
Research Site
Miyagi, D3250C00057, Japan
Research Site
Numakunai, D3250C00057, Japan
Research Site
Okayama, D3250C00057, Japan
Research Site
Okinawa, D3250C00057, Japan
Research Site
Osaka, D3250C00057, Japan
Research Site
Ōita, D3250C00057, Japan
Research Site
Saitama, D3250C00057, Japan
Research Site
Shiga, D3250C00057, Japan
Research Site
Tochigi, D3250C00057, Japan
Research Site
Tokyo, D3250C00057, Japan
Research Site
Yamagata, D3250C00057, Japan
Research Site
Yamaguchi, D3250C00057, Japan
Primary Completion
September 10, 2024
Actual (reported)Study Completion
September 10, 2024
Actual (reported)Last Updated
September 2, 2025
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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