Fasenra Pediatric Japan Post-Marketing Study(PMS) (NCT06427876) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Fasenra Pediatric Japan Post-Marketing Study(PMS)
Japan40 participantsStarted 2024-07-16
Plain-language 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
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is specifically being conducted in Japan as a post-marketing study for children with bronchial asthma — is my child eligible to participate given where we live and where they receive care?
2Since this study is tracking adverse drug reactions (ADRs) as its main focus, what kinds of side effects have already been seen with Fasenra (benralizumab) in adults or adolescents that we should be aware of before considering this?
3This is listed as 'Phase NA,' which typically means it's a real-world safety monitoring study rather than a controlled clinical trial — does that change how you'd weigh the risks and benefits compared to enrolling in a more traditional phase 2 or 3 trial?
4Given that the primary goal here is to collect safety data in a pediatric population rather than to test whether the drug works better than existing options, would my child potentially benefit more from an established standard-of-care treatment for their asthma right now?
5What would participating in this study actually involve day-to-day for my child — how many visits, what monitoring, and how does that fit with managing their asthma care overall?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.