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Clinical Trials in Japan / NCT06427876
Active, not recruiting Observational

Fasenra Pediatric Japan Post-Marketing Study(PMS)

NCT06427876 · tracked via the Priya Life Science Japan tracker
Sponsor
AstraZeneca
Phase
Observational
Started
2024-07-16
Last updated
2026-09-10

Condition(s) studied

Bronchial Asthma

Study summary

The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra).

1. Development of unexpected related AEs\*
2. To grasp development of related AEs\* in the real-world post-marketing setting.
3. Effectiveness (pulmonary function and asthma control) \* AEs investigator or MAH considers that there is a reasonable possibility that the experience may have been caused by the drug

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: The evaluable patients in children aged ≥6 years to \<15 years are those 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: none

Primary outcome measure(s)

  • Incidence of ADRs — from baseline to 1year
    The incidence of ADRs related to Fasenra Safety Specification, Serious infection and other

Trial sites (9)

FacilityCityRegionStatus
Research Site Chiba Japan
Research Site Hiroshima Japan
Research Site Hokkaido Japan
Research Site Hyōgo Japan
Research Site Ibaraki Japan
Research Site Mie Japan
Research Site Okayama Japan
Research Site Osaka Japan
Research Site Saitama Japan

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Other trials for the same condition

Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06427876 on ClinicalTrials.gov ↗ ← All trials in Japan