RecruitingNCT06427876

Fasenra Pediatric Japan Post-Marketing Study(PMS)

FASENRA® Subcutaneous Injection 30 mg / 10mg Syringe Protocol of Specific Drug Use Result Study for Pediatric Patients


Sponsor

AstraZeneca

Enrollment

40 participants

Start Date

Jul 16, 2024

Study Type

OBSERVATIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This is a post-marketing safety study for Fasenra (benralizumab) in Japanese children with severe, hard-to-control asthma. It is monitoring how well the medication works and whether it is safe when used in real-world clinical practice in children who are receiving it for the first time. **You may be eligible if...** - Your child is between 6 and under 15 years old - Your child has been diagnosed with bronchial asthma that could not be adequately controlled with previous standard treatments - Your child is being prescribed Fasenra for the first time **You may NOT be eligible if...** - There are no specific exclusion criteria listed for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(11)

Research Site

Aichi, Japan

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

Osaka, Japan

Research Site

Saitama, Japan

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NCT06427876


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