Current partner codePEPTIDESDE
NCT04057131·Not applicable·OBSERVATIONAL

FIRAZYR General Drug Use-Results Survey (Japan)

Status

Completed

Phase

Not applicable

Enrollment

179

Locations

18

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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).

Interventions

Treatment arms and agents.

DRUG

Firazyr

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

Timeline

From registration to results.

  1. First posted

    Aug 15, 2019

  2. Study start

    Nov 20, 2018

  3. Primary completion

    Jul 29, 2024

  4. Study completion

    Jul 29, 2024

  5. Results posted

    Feb 21, 2025

  6. Registry updated

    Feb 21, 2025

Outcomes

What the study measures.

Primary outcomes

Number of Participants With Adverse Events

Time frame · 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

Time frame · 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

Time frame · 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

Time frame · 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

Time frame · 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

Time frame · 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 outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Hereditary angioedema (HAE) participants in Japan who receive FIRAZYR for first time in the real world clinical setting. Exclusion Criteria

Study locations

18 registered sites.

Japan. Showing up to 24 locations stored in the fast local snapshot.

Nagoya-city

Nagoya, Aichi-ken, Japan

Toyohashi-city

Toyohashi, Aichi-ken, 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

Takatsuki-city

Takatsuki, Osaka, Japan

Kawagoe-city

Kawagoe, Saitama, Japan

Soka-city

Sōka, Saitama, Japan

Numazu-city

Numazu, Shizuoka, Japan

Shimada-city

Shimada, Shizuoka, Japan

Yaezu-city

Yaezu, Shizuoka, Japan

Tachikawa-city

Tachikawa, Tokyo, Japan

Niigata-city

Niigata, Japan

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Icatibant.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.