Trials / Completed
CompletedNCT05578417
A Study to Review the Treatment and Outcomes of Teenagers and Adults With Non-histaminergic Angioedema With Normal C1 Inhibitor in Canada
Treatment and Outcomes of Patients Identified With Non-Histaminergic Angioedema With Normal C1 Inhibitor in Canada
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No Intervention | As this is an observational study, no intervention will be administered. |
Timeline
- Start date
- 2023-06-15
- Primary completion
- 2024-03-31
- Completion
- 2024-06-30
- First posted
- 2022-10-13
- Last updated
- 2024-07-30
Locations
6 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT05578417. Inclusion in this directory is not an endorsement.