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FIRAZYR General Drug Use-Results Survey (Japan)

IDENTIFIERS
Trial Protocol: SHP667-401
Clinicaltrials.gov: NCT04057131
PURPOSE

The objectives of this survey are to collect data to evaluate the safety and efficacy of Firazyr (Icatibant acetate) in the post-marketing phase in patients diagnosed with Hereditary Angioedema (HAE).

Recruiting
JP

Trial at a glance

What medical condition is being studied?   Hereditary Angioedema (HAE)
What is the trial testing?   Firazyr
Are placebos part of the trial?   No
How many participants are being enrolled?   75
When is the trial being conducted?    - 

Key requirements

Sex   
All
Age   
All
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial phase:   N/A
Trial Type:   Observational
Trial Arms/Groups or Cohorts:   
Firazyr: Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.
Intervention:   Firazyr
Primary Outcome Measure(s):   
Number of Participants with Adverse Drug Reactions [Time Frame: 4 Years]
Time to Treatment for Attack [Time Frame: 3 Months]
Time to First Symptom Relief [Time Frame: 3 Months]
Time to Complete Resolution of Attack [Time Frame: 3 Months]
Total Duration of Attack [Time Frame: 3 Months]
Entry Criteria:
Patients with confirmed diagnosis of Hereditary Angioedema (HAE) Patients who are treated with Firazyr

Trial Locations

Any
Recruiting
Any
RESULTS
Nagoya-city

453-0046, Japan

Recruiting
6,781 miles (10,913 km)  awayfrom
Massachusetts, United States
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Toyohashi-city

441-8570, Japan

Recruiting
6,797 miles (10,939 km)  awayfrom
Massachusetts, United States
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Maebashi-city

371-8511, Japan

Recruiting
6,656 miles (10,711 km)  awayfrom
Massachusetts, United States
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Asahikawa-city

070-0034, Japan

Recruiting
6,120 miles (9,849 km)  awayfrom
Massachusetts, United States
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Fukagawa-city

074-0006, Japan

Recruiting
6,129 miles (9,864 km)  awayfrom
Massachusetts, United States
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Rumoi-city

077-0011, Japan

Recruiting
6,124 miles (9,855 km)  awayfrom
Massachusetts, United States
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Sapporo-city

002-8072, Japan

Recruiting
6,178 miles (9,943 km)  awayfrom
Massachusetts, United States
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Kasama-city

309-1703, Japan

Recruiting
6,632 miles (10,674 km)  awayfrom
Massachusetts, United States
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Maizuru-city

625-8585, Japan

Recruiting
6,791 miles (10,929 km)  awayfrom
Massachusetts, United States
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Kishiwada-city

596-0042, Japan

Recruiting
6,856 miles (11,033 km)  awayfrom
Massachusetts, United States
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Takatsuki-city

569-0096, Japan

Recruiting
6,826 miles (10,985 km)  awayfrom
Massachusetts, United States
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Kawagoe-city

350-8550, Japan

Recruiting
6,676 miles (10,744 km)  awayfrom
Massachusetts, United States
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Soka-city

340-0041, Japan

Recruiting
6,676 miles (10,744 km)  awayfrom
Massachusetts, United States
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Numazu-city

410-0302, Japan

Recruiting
6,742 miles (10,851 km)  awayfrom
Massachusetts, United States
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Shimada-city

427-8502, Japan

Recruiting
6,774 miles (10,902 km)  awayfrom
Massachusetts, United States
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Yaezu-city

425-0088, Japan

Recruiting
6,770 miles (10,895 km)  awayfrom
Massachusetts, United States
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Tachikawa-city

190-0014, Japan

Recruiting
6,693 miles (10,772 km)  awayfrom
Massachusetts, United States
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Niigata-city

950-1197, Japan

Recruiting
6,563 miles (10,561 km)  awayfrom
Massachusetts, United States
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View all (18)
Trial Protocol ID: SHP667-401
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