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The main aim of this study is to describe the characteristics of participants, check for number of hereditary angioedema (HAE) cases, their treatment and outcomes. Another aim is to check how the healthcare facilities were utilized for treatment.
Participants' data will be taken from their medical records (charts), which were already collected as a part of their routine care between January 1, 2012, and January 1, 2022.
This is a non-interventional, retrospective, observational study of participants with Hereditary Angioedema with normal C1 esterase inhibitor (HAE) and Non-histaminergic Angioedema (NHAE) with normal C1-inhibitor function (nC1-INH) receiving various treatments between January 1, 2012, and January 1, 2022. The study will assess case numbers, treatments, outcomes, and healthcare resource utilization in the real-world setting.
This study will enroll approximately 90 to 150 participants. Participants will be enrolled in the following two cohorts:
This study will have a retrospective data collection from January 1, 2012 to January 1, 2022 by using data from the participant medical charts that were already collected as part of routine care.
This multi-center trial will be conducted in Canada. The overall time for data collection in this study will be approximately 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAE nC1-INH | Participants with HAE nC1-INH will be observed retrospectively for the treatments they receive and their outcomes in the real-world setting from January 1, 2012, to January 1, 2022. |
| |
| NHAE nC1-INH | Participants with NHAE nC1-INH will be observed retrospectively for the treatments they receive and their outcomes in the real-world setting from January 1, 2012, to January 1, 2022. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | As this is an observational study, no intervention will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Diagnosed With HAE nC1-INH at Each Site | Up to approximately 10 years | |
| Number of Participants Diagnosed With NHAE nC1-INH at Each Site | Up to approximately 10 years | |
| Number of Participants Categorized by Type of Treatments Received by Participants | Up to approximately 10 years | |
| Average Dose for Each Type of Treatment Received by Participants | Up to approximately 10 years | |
| Average Duration of Treatment for Each Type of Treatment Received by Participants | Up to approximately 10 years | |
| Number of Participants Categorized by Type of Settings Where Treatment was Received | Categories of treatment settings include: home, hospital, physician office, emergency room visits (ER), and other. | Up to approximately 10 years |
| Number of Participants Receiving Multiple Long-Term Prophylaxis (LTP) Therapies at Once | Number of participants will be reported by number of LTP therapies received at once. | Up to approximately 10 years |
| Number of Participants Receiving Multiple LTP Therapies Categorized by Combination and Order of Treatments Received | Up to approximately 10 years | |
| Number of Attacks Occurring per Three-Months |
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Inclusion Criteria:
1. Participants ≥12 years of age with HAE nC1-INH or NHAE nC1-INH diagnosed by an HAE treating specialist based on some or all of the following:
Exclusion Criteria:
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Participants with confirmed diagnosis of HAE nC1-INH or NHAE nC1-INH prior to January 1, 2022.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Health Services | Calgary | Alberta | T2N 2T9 | Canada | ||
| Alberta Health Services |
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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.
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| Before and after initiation of treatment up to end of the study (up to approximately 10 years) |
| Number of Participants Categorized by Severity of Attack per Three Months | Categories of severity are planned to include ER, use of rescue medication(s), (%) intubation, hospitalization, and laryngeal involvement. | Before and after initiation of treatment up to end of the study (up to approximately 10 years) |
| Number of Participants by Body Sites Affected by Attacks per Three Months | Body sites will include face, lip, tongue, gastrointestinal (GI) system, larynx, extremities, and other. | Before and after initiation of treatment up to end of the study (up to approximately 10 years) |
| Number of Participants with Symptoms of the Attack | Up to approximately 10 years |
| Time from Treatment (On-demand Therapy) to Symptom Improvement/Resolution | Up to approximately 10 years |
| Number of Primary Care Visits per Year Associated With Management of HAE nC1-INH or NHAE nC1-INH | Up to approximately 10 years |
| Number of Walk-in Visits per Year Associated With Management of HAE nC1-INH or NHAE nC1-INH | Up to approximately 10 years |
| Number of Unscheduled Physician Visits per Year Associated With Management of HAE nC1-INH or NHAE nC1-INH | Up to approximately 10 years |
| Number of Emergency Room Visits per Year Associated With Management of HAE nC1-INH or NHAE nC1-INH | Up to approximately 10 years |
| Number of Hospitalizations per Year Associated With Management of HAE nC1-INH or NHAE nC1-INH | Up to approximately 10 years |
| Number of Intubations per Year Associated With Management of HAE nC1-INH or NHAE nC1-INH | Up to approximately 10 years |
| Edmonton |
| Alberta |
| T6G 2B7 |
| Canada |
| Vancouver Allergy Clinic | Vancouver | British Columbia | V5Z 1H8 | Canada |
| University of Manitoba | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Hamilton Health Science Corporation | Hamilton | Ontario | L8S 4K1 | Canada |
| CHU de Québec - Université Laval | Québec | G1V 4G2 | Canada |
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| D000799 | Angioedema |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
| 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 |
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