FIRAZYR General Drug Use-Results Survey (Japan)

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).

Study Overview

• Status: Completed
• Conditions: Hereditary Angioedema (HAE)
• Intervention / Treatment: Drug: Firazyr

Detailed Description

FIRAZYR General Drug Use-Results Survey (Japan)

• Study Type: Observational
• Enrollment (Actual): 304

Contacts and Locations

Study Locations

• Japan
  • Niigata, Japan, 950-1197
    • Niigata-city
  • Aichi
    • Nagoya, Aichi, Japan, 453-0046
      • Nagoya-city
    • Toyohashi, Aichi, Japan, 441-8570
      • Toyohashi-city
  • Gunma
    • Maebashi, Gunma, Japan, 371-8511
      • Maebashi-city
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-0034
      • Asahikawa-city
    • Fukagawa, Hokkaido, Japan, 074-0006
      • Fukagawa-city
    • Rumoi, Hokkaido, Japan, 077-0011
      • Rumoi-city
    • Sapporo, Hokkaido, Japan, 002-8072
      • Sapporo-city
  • Ibaraki
    • Kasama, Ibaraki, Japan, 309-1703
      • Kasama-city
  • Kyoto
    • Maizuru, Kyoto, Japan, 625-8585
      • Maizuru-city
  • Osaka
    • Kishiwada, Osaka, Japan, 596-0042
      • Kishiwada-city
    • Takatsuki, Osaka, Japan, 569-0096
      • Takatsuki-city
  • Saitama
    • Kawagoe, Saitama, Japan, 350-8550
      • Kawagoe-city
    • Soka, Saitama, Japan, 340-0041
      • Soka-city
  • Shizuoka
    • Numazu, Shizuoka, Japan, 410-0302
      • Numazu-city
    • Shimada, Shizuoka, Japan, 427-8502
      • Shimada-city
    • Yaezu, Shizuoka, Japan, 425-0088
      • Yaezu-city
  • Tokyo
    • Tachikawa, Tokyo, Japan, 190-0014
      • Tachikawa-city

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hereditary angioedema (HAE) patients in Japan who receive FIRAZYR for first time in the real world clinical setting are eligible for enrollment in this survey.

Description

Inclusion Criteria:

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

Exclusion Criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Firazyr; Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.	Drug: Firazyr; Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.; Other Names: Icatibant acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Drug Reactions	Number of participants with adverse drug reactions will be assessed.	4 Years
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
Time to First Symptom Relief	Time to first symptom relief will be assessed.	3 Months
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
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

Collaborators and Investigators

• Sponsor: Shire
• Collaborators: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): March 22, 2024

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Angioedema; Angioedemas, Hereditary; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Complement Inactivating Agents; Bradykinin B2 Receptor Antagonists; Bradykinin Receptor Antagonists; Icatibant
• Other Study ID Numbers: SHP667-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No