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

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

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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (18): Maebashi-city
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Maebashi, Gunma, Japan
Rumoi-city
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Rumoi, Hokkaido, Japan
Fukagawa-city
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Fukagawa, Hokkaido, Japan
Toyohashi-city
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Toyohashi, Aichi, Japan
Asahikawa-city
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Asahikawa, Hokkaido, Japan
Maizuru-city
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Maizuru, Kyoto, Japan
Takatsuki-city
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Takatsuki, Osaka, Japan
Shimada-city
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Shimada, Shizuoka, Japan
Niigata-city
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Niigata, Japan
Nagoya-city
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Nagoya, Aichi, Japan
Sapporo-city
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Sapporo, Hokkaido, Japan
Kasama-city
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Kasama, Ibaraki, Japan
Kawagoe-city
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Kawagoe, Saitama, Japan
Kishiwada-city
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Kishiwada, Osaka, Japan
Soka-city
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Soka, Saitama, Japan
Numazu-city
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Numazu, Shizuoka, Japan
Yaezu-city
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Yaezu, Shizuoka, Japan
Tachikawa-city
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Tachikawa, Tokyo, Japan