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NCT03588546 Clinical Trial

FASENRA SCEI for Long-term Use

Asthma Clinical Trial

Official title:
FASENRA Subcutaneous Injection 30 mg Syringe Specific Clinical Experience Investigation for Long-term Use

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03588546
Other study ID # D3250C00057
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 31, 2018
Est. completion date April 30, 2025

Study information
Verified date March 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 653
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site Aichi
Japan Research Site Akita
Japan Research Site Aomori
Japan Research Site Chiba
Japan Research Site Ehime
Japan Research Site Fukuoka
Japan Research Site Gunma
Japan Research Site Hiroshima
Japan Research Site Hokkaido
Japan Research Site Hyogo
Japan Research Site Ibaraki
Japan Research Site Iwate
Japan Research Site Kagawa
Japan Research Site Kagoshima
Japan Research Site Kanagawa
Japan Research Site Kumamoto
Japan Research Site Kyoto
Japan Research Site Mie
Japan Research Site Miyagi
Japan Research Site Oita
Japan Research Site Okayama
Japan Research Site Okinawa
Japan Research Site Osaka
Japan Research Site Saitama
Japan Research Site Shiga
Japan Research Site Tochigi
Japan Research Site Tokyo
Japan Research Site Yamagata
Japan Research Site Yamaguchi

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidences of adverse drug reactions (ADRs) [all ADRS, unexpected ADRs and key investigational safety specification (serious infection)] 1 year
Secondary 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
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