A Study to Review the Treatment and Outcomes of Teenagers and Adults With Non-histaminergic Angioedema With Normal C1 Inhibitor in Canada

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-15

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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:

* Participants with HAE nC1-INH
* Participants with NHAE nC1-INH

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.

Conditions

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Hereditary Angioedema (HAE) Angioedema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No Intervention

Intervention Type OTHER

As this is an observational study, no intervention will be administered.

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.

No Intervention

Intervention Type OTHER

As this is an observational study, no intervention will be administered.

Interventions

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No Intervention

As this is an observational study, no intervention will be administered.

Intervention Type OTHER

Eligibility Criteria

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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:

1. Recurrent angioedema as documented by a healthcare professional within specialist charts
2. Normal C4
3. Normal C1 level and function
4. Condition worsened with estrogen if estrogen is/was being received
5. Lack of response to corticosteroid and high-dose regular and/or prophylactic antihistamine(s) treatment(s)
6. Family history of non-histaminergic angioedema for patients with HAE nC1-INH

Exclusion Criteria

1. Other types of angioedema (type-1 HAE, type-2 HAE, acquired angioedema, etc.)
2. Not meeting the above diagnostic criteria for inclusion
3. Response to treatments used for histamine-related angioedema

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No