An observational study in Hereditary Angioedema (HAE) and Angioedema, sponsored by Takeda. Completed at 6 sites in Canada. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Takeda · Observational
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.
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 43 observational studies indexed under Angioedemas, Hereditary.
Browse Angioedemas, Hereditary studies →Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.
Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with confirmed diagnosis of HAE nC1-INH or NHAE nC1-INH prior to January 1, 2022.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: No Intervention
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.
Other: No Intervention
As this is an observational study, no intervention will be administered.
Number of Participants Diagnosed With HAE nC1-INH at Each Site
Time frame: Up to approximately 10 years
Number of Participants Diagnosed With NHAE nC1-INH at Each Site
Time frame: Up to approximately 10 years
Number of Participants Categorized by Type of Treatments Received by Participants
Time frame: Up to approximately 10 years
Average Dose for Each Type of Treatment Received by Participants
Time frame: Up to approximately 10 years
Average Duration of Treatment for Each Type of Treatment Received by Participants
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 10 years
Number of Participants Receiving Multiple LTP Therapies Categorized by Combination and Order of Treatments Received
Time frame: Up to approximately 10 years
Number of Attacks Occurring per Three-Months
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to approximately 10 years
Time from Treatment (On-demand Therapy) to Symptom Improvement/Resolution
Time frame: Up to approximately 10 years
Number of Primary Care Visits per Year Associated With Management of HAE nC1-INH or NHAE nC1-INH
Time frame: Up to approximately 10 years
Number of Walk-in Visits per Year Associated With Management of HAE nC1-INH or NHAE nC1-INH
Time frame: Up to approximately 10 years
Number of Unscheduled Physician Visits per Year Associated With Management of HAE nC1-INH or NHAE nC1-INH
Time frame: Up to approximately 10 years
Number of Emergency Room Visits per Year Associated With Management of HAE nC1-INH or NHAE nC1-INH
Time frame: Up to approximately 10 years
Number of Hospitalizations per Year Associated With Management of HAE nC1-INH or NHAE nC1-INH
Time frame: Up to approximately 10 years
Number of Intubations per Year Associated With Management of HAE nC1-INH or NHAE nC1-INH
Time frame: Up to approximately 10 years
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Data sharing details ↗ · vivli.org
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.