DRUG
Firazyr
Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.
Status
Completed
Phase
Not applicable
Enrollment
179
Locations
18
Results
Posted
Publications
0
Study summary
The objectives of this survey are to collect data to report the safety and efficacy of Firazyr (Icatibant acetate) in the post-marketing phase in participants diagnosed with Hereditary Angioedema (HAE).
Interventions
DRUG
Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.
Timeline
First posted
Aug 15, 2019
Study start
Nov 20, 2018
Primary completion
Jul 29, 2024
Study completion
Jul 29, 2024
Results posted
Feb 21, 2025
Registry updated
Feb 21, 2025
Outcomes
Number of Participants With Adverse Events
Time frame · Baseline up to end of the study (up to approximately 68 months)
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Number of Participants With Adverse Drug Reaction
Time frame · Baseline up to end of the study (up to approximately 68 months)
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. Adverse drug reaction refers to AE related to administered drug.
Time to Treatment for Attack
Time frame · Up to 3 months
Time to treatment for attack defined as the time between the onset of the attack and the first injection of treatment. Time to treatment for attack was assessed and reported.
Time to First Symptom Relief
Time frame · Up to 3 months
Time to first symptom relief defined as the time between the first injection of treatment and first symptom relief. Time to first symptom relief was assessed and reported.
Time to Complete Resolution of Attack
Time frame · Up to 3 months
Time to complete resolution of attack defined as the time between the first injection of treatment and the complete resolution of all symptoms. Time to complete resolution of attack was assessed and reported.
Total Duration of Attack
Time frame · Up to 3 months
Total duration of attack defined as the time between the onset of the attack and the complete resolution of all symptoms. Total duration of attack was assessed and reported.
Not reported in the indexed record.
Eligibility
Inclusion Criteria: * Hereditary angioedema (HAE) participants in Japan who receive FIRAZYR for first time in the real world clinical setting. Exclusion Criteria
Study locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
Nagoya-city
Nagoya, Aichi-ken, Japan
Toyohashi-city
Toyohashi, Aichi-ken, Japan
Maebashi-city
Maebashi, Gunma, Japan
Asahikawa-city
Asahikawa, Hokkaido, Japan
Fukagawa-city
Fukagawa, Hokkaido, Japan
Rumoi-city
Rumoi, Hokkaido, Japan
Sapporo-city
Sapporo, Hokkaido, Japan
Kasama-city
Kasama, Ibaraki, Japan
Maizuru-city
Maizuru, Kyoto, Japan
Kishiwada-city
Kishiwada, Osaka, Japan
Takatsuki-city
Takatsuki, Osaka, Japan
Kawagoe-city
Kawagoe, Saitama, Japan
Soka-city
Sōka, Saitama, Japan
Numazu-city
Numazu, Shizuoka, Japan
Shimada-city
Shimada, Shizuoka, Japan
Yaezu-city
Yaezu, Shizuoka, Japan
Tachikawa-city
Tachikawa, Tokyo, Japan
Niigata-city
Niigata, Japan
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.