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NCT04057131 Clinical Trial

FIRAZYR General Drug Use-Results Survey (Japan)

Hereditary Angioedema (HAE) Clinical Trial

Official title:
FIRAZYR General Drug Use-Results Survey (Japan)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04057131
Other study ID # SHP667-401
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 9, 2019
Est. completion date March 22, 2024

Study information
Verified date March 2024
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 304
Est. completion date March 22, 2024
Est. primary completion date March 22, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Hereditary angioedema (HAE) participants in Japan who receive FIRAZYR for first time in the real world clinical setting. Exclusion Criteria

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Japan Asahikawa-city Asahikawa Hokkaido
Japan Fukagawa-city Fukagawa Hokkaido
Japan Kasama-city Kasama Ibaraki
Japan Kawagoe-city Kawagoe Saitama
Japan Kishiwada-city Kishiwada Osaka
Japan Maebashi-city Maebashi Gunma
Japan Maizuru-city Maizuru Kyoto
Japan Nagoya-city Nagoya Aichi
Japan Niigata-city Niigata
Japan Numazu-city Numazu Shizuoka
Japan Rumoi-city Rumoi Hokkaido
Japan Sapporo-city Sapporo Hokkaido
Japan Shimada-city Shimada Shizuoka
Japan Soka-city Soka Saitama
Japan Tachikawa-city Tachikawa Tokyo
Japan Takatsuki-city Takatsuki Osaka
Japan Toyohashi-city Toyohashi Aichi
Japan Yaezu-city Yaezu Shizuoka

Sponsors (2)
Lead Sponsor Collaborator
Shire Takeda

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Drug Reactions Number of participants with adverse drug reactions will be assessed. 4 Years
Primary Time to Treatment for Attack 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 will be assessed. 3 Months
Primary Time to First Symptom Relief Time to first symptom relief will be assessed. 3 Months
Primary Time to Complete Resolution of Attack 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 will be assessed. 3 Months
Primary Total Duration of Attack 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 will be assessed. 3 Months
See also
  Status Clinical Trial Phase
Completed NCT02865720 - Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE) Phase 3
Completed NCT04861090 - A Study in Teenagers and Adults With Hereditary Angioedema (HAE) Type I or Type II Who Use Lanadelumab as Long-Term Prophylaxis
Recruiting NCT05489640 - A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home
Completed NCT02584959 - Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema Phase 3
Completed NCT01826916 - EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema Phase 2
Recruiting NCT05819775 - CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema Phase 3
Recruiting NCT05397431 - A Survey of Lanadelumab in Participants With Hereditary Angioedema
Completed NCT02741596 - Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE Phase 3
Completed NCT02093923 - A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants Phase 1
Completed NCT01541423 - A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema
Completed NCT03845400 - A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America
Completed NCT02586805 - Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE Phase 3
Completed NCT02052141 - Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema Phase 3
Completed NCT03888755 - A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants Phase 3
Recruiting NCT05147181 - A Study With Lanadelumab in Persons With Hereditary Angioedema (HAE) in Poland
Recruiting NCT05469789 - A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)
Completed NCT05460325 - A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE) Phase 3
Completed NCT01095510 - CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12 Phase 2
Recruiting NCT05578417 - A Study to Review the Treatment and Outcomes of Teenagers and Adults With Non-histaminergic Angioedema With Normal C1 Inhibitor in Canada
Withdrawn NCT01253382 - Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema Phase 2/Phase 3

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