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NCT Number: NCT06427876

Fasenra Pediatric Japan Post-Marketing Study(PMS)

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Bronchial Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

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About this study

This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Act on Securing Quality, Effectiveness and Safety of Products Including Pharmaceuticals and Medical Devices.

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).

  • Development of unexpected related AEs*
  • To grasp development of related AEs* in the real-world post-marketing setting.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of ADRs

    Time frame: from baseline to 1year

    The incidence of ADRs related to Fasenra Safety Specification, Serious infection and other

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 24, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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