FIRAZYR General Drug Use-Results Survey (Japan)
1 other identifier
observational
179
1 country
18
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 20, 2018
CompletedFirst Submitted
Initial submission to the registry
August 13, 2019
CompletedFirst Posted
Study publicly available on registry
August 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2024
CompletedResults Posted
Study results publicly available
February 21, 2025
CompletedFebruary 21, 2025
February 1, 2025
5.7 years
August 13, 2019
January 5, 2025
February 2, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
Number of Participants With Adverse Events
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.
Baseline up to end of the study (up to approximately 68 months)
Number of Participants With Adverse Drug Reaction
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.
Baseline up to end of the study (up to approximately 68 months)
Time to Treatment for Attack
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.
Up to 3 months
Time to First Symptom Relief
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.
Up to 3 months
Time to Complete Resolution of Attack
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.
Up to 3 months
Total Duration of Attack
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.
Up to 3 months
Study Arms (1)
Firazyr
Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.
Interventions
Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.
Eligibility Criteria
Hereditary angioedema (HAE) patients in Japan who receive FIRAZYR for first time in the real world clinical setting are eligible for enrollment in this survey.
You may qualify if:
- Hereditary angioedema (HAE) participants in Japan who receive FIRAZYR for first time in the real world clinical setting.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Nagoya-city
Nagoya, Aichi-ken, 453-0046, Japan
Toyohashi-city
Toyohashi, Aichi-ken, 441-8570, Japan
Maebashi-city
Maebashi, Gunma, 371-8511, Japan
Asahikawa-city
Asahikawa, Hokkaido, 070-0034, Japan
Fukagawa-city
Fukagawa, Hokkaido, 074-0006, Japan
Rumoi-city
Rumoi, Hokkaido, 077-0011, Japan
Sapporo-city
Sapporo, Hokkaido, 002-8072, Japan
Kasama-city
Kasama, Ibaraki, 309-1703, Japan
Maizuru-city
Maizuru, Kyoto, 625-8585, Japan
Kishiwada-city
Kishiwada, Osaka, 596-0042, Japan
Takatsuki-city
Takatsuki, Osaka, 569-0096, Japan
Kawagoe-city
Kawagoe, Saitama, 350-8550, Japan
Soka-city
Sōka, Saitama, 340-0041, Japan
Numazu-city
Numazu, Shizuoka, 410-0302, Japan
Shimada-city
Shimada, Shizuoka, 427-8502, Japan
Yaezu-city
Yaezu, Shizuoka, 425-0088, Japan
Tachikawa-city
Tachikawa, Tokyo, 190-0014, Japan
Niigata-city
Niigata, 950-1197, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2019
First Posted
August 15, 2019
Study Start
November 20, 2018
Primary Completion
July 29, 2024
Study Completion
July 29, 2024
Last Updated
February 21, 2025
Results First Posted
February 21, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.