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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Firazyr | Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firazyr | Drug | Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 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. | Baseline up to end of the study (up to approximately 68 months) |
| Number of Participants With Adverse Drug Reaction | 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. | Baseline up to end of the study (up to approximately 68 months) |
| 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 was assessed and reported. | Up to 3 months |
| Time to First Symptom Relief | 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. | Up to 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 was assessed and reported. |
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Inclusion Criteria:
Exclusion Criteria
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya-city | Nagoya | Aichi-ken | 453-0046 | Japan | ||
| Toyohashi-city |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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.
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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.
Participants with Hereditary Angioedema (HAE) received Icatibant acetate subcutaneous infusion as part of a routine medical care.
Participants took part in the survey at 93 investigative sites in Japan, from 20 Nov 2018 to 29 Jul 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Icatibant Acetate Subcutaneous Infusion | Participants with Hereditary Angioedema (HAE) received Icatibant acetate subcutaneous infusion as part of a routine medical care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Icatibant Acetate Subcutaneous Infusion | Participants with Hereditary Angioedema (HAE) received Icatibant acetate subcutaneous infusion as part of a routine medical care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The number analyzed is the number of participants with data available for analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 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. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Baseline up to end of the study (up to approximately 68 months) |
|
Baseline up to end of the study (up to approximately 68 months)
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Icatibant Acetate Subcutaneous Infusion | Participants with Hereditary Angioedema (HAE) received Icatibant acetate subcutaneous infusion as part of a routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA/J v26.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA/J v26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2023 | Jan 5, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2024 | Jan 5, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
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| ID | Term |
|---|---|
| C065679 | icatibant |
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|
| Up to 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 was assessed and reported. | Up to 3 months |
| Toyohashi |
| Aichi-ken |
| 441-8570 |
| Japan |
| Maebashi-city | Maebashi | Gunma | 371-8511 | Japan |
| Asahikawa-city | Asahikawa | Hokkaido | 070-0034 | Japan |
| Fukagawa-city | Fukagawa | Hokkaido | 074-0006 | Japan |
| Rumoi-city | Rumoi | Hokkaido | 077-0011 | Japan |
| Sapporo-city | Sapporo | Hokkaido | 002-8072 | Japan |
| Kasama-city | Kasama | Ibaraki | 309-1703 | Japan |
| Maizuru-city | Maizuru | Kyoto | 625-8585 | Japan |
| Kishiwada-city | Kishiwada | Osaka | 596-0042 | Japan |
| Takatsuki-city | Takatsuki | Osaka | 569-0096 | Japan |
| Kawagoe-city | Kawagoe | Saitama | 350-8550 | Japan |
| Soka-city | Sōka | Saitama | 340-0041 | Japan |
| Numazu-city | Numazu | Shizuoka | 410-0302 | Japan |
| Shimada-city | Shimada | Shizuoka | 427-8502 | Japan |
| Yaezu-city | Yaezu | Shizuoka | 425-0088 | Japan |
| Tachikawa-city | Tachikawa | Tokyo | 190-0014 | Japan |
| Niigata-city | Niigata | 950-1197 | Japan |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Unknown: Data could not be collected. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With Adverse Drug Reaction | 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. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | Baseline up to end of the study (up to approximately 68 months) |
|
|
|
| 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 was assessed and reported. | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. | Posted | Median | Inter-Quartile Range | minutes | Up to 3 months |
|
|
|
| Primary | Time to First Symptom Relief | 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. | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. | Posted | Median | Inter-Quartile Range | minutes | Up to 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 was assessed and reported. | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. | Posted | Median | Inter-Quartile Range | minutes | Up to 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 was assessed and reported. | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. | Posted | Median | Inter-Quartile Range | minutes | Up to 3 months |
|
|
|
| 0 |
| 155 |
| 1 |
| 155 |
| 7 |
| 155 |
| Injury | Injury, poisoning and procedural complications | MedDRA/J v26.0 | Systematic Assessment |
|
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| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |