FIRAZYR General Drug Use-Results Survey (Japan)

NCT ID: NCT04057131

Last Updated: 2025-02-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

179 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-20

Study Completion Date

2024-07-29

Brief Summary

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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

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Conditions

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Hereditary Angioedema (HAE)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Firazyr

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

Firazyr

Intervention Type DRUG

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

Interventions

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Firazyr

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

Intervention Type DRUG

Other Intervention Names

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Icatibant acetate

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role collaborator

Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Nagoya-city

Nagoya, Aichi-ken, Japan

Site Status

Toyohashi-city

Toyohashi, Aichi-ken, Japan

Site Status

Maebashi-city

Maebashi, Gunma, Japan

Site Status

Asahikawa-city

Asahikawa, Hokkaido, Japan

Site Status

Fukagawa-city

Fukagawa, Hokkaido, Japan

Site Status

Rumoi-city

Rumoi, Hokkaido, Japan

Site Status

Sapporo-city

Sapporo, Hokkaido, Japan

Site Status

Kasama-city

Kasama, Ibaraki, Japan

Site Status

Maizuru-city

Maizuru, Kyoto, Japan

Site Status

Kishiwada-city

Kishiwada, Osaka, Japan

Site Status

Takatsuki-city

Takatsuki, Osaka, Japan

Site Status

Kawagoe-city

Kawagoe, Saitama, Japan

Site Status

Soka-city

Sōka, Saitama, Japan

Site Status

Numazu-city

Numazu, Shizuoka, Japan

Site Status

Shimada-city

Shimada, Shizuoka, Japan

Site Status

Yaezu-city

Yaezu, Shizuoka, Japan

Site Status

Tachikawa-city

Tachikawa, Tokyo, Japan

Site Status

Niigata-city

Niigata, , Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://clinicaltrials.takeda.com/study-detail/5f6b5fe84db2bf003ab47b02

To obtain more information on the study, click here/on this link

Other Identifiers

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SHP667-401

Identifier Type: -

Identifier Source: org_study_id

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