FIRAZYR General Drug Use-Results Survey (Japan)

Completed

• Conditions: Hereditary Angioedema (HAE)
• Interventions: Drug: Firazyr

• Registration Number: NCT04057131
• Lead Sponsor: Shire

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-20
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-15
• Primary Completion: 2024-07-29
• Study Completion: 2024-07-29
• Results First Submitted: 2025-01-05
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-02
• Last Update Submitted: 2025-02-02
• Results First Posted: 2025-02-21
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

• Hereditary angioedema (HAE) participants in Japan who receive FIRAZYR for first time in the real world clinical setting.

Exclusion Criteria

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Firazyr	Firazyr	Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	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	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	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	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	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	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.

Trial Locations

Locations (18)

Nagoya-city; 🇯🇵 Nagoya, Aichi, Japan

Toyohashi-city; 🇯🇵 Toyohashi, Aichi, 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

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