A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema
NCT ID: NCT07293364
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
514 participants
INTERVENTIONAL
2026-01-07
2027-01-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main goal of the study is to see how well a test focusing on the C1INH function alone works to diagnose HAE-C1INH as compared to the tests used in normal clinical practice (standard of care or SoC) in Algeria. Another aim is to determine a reference value (helps in determining the accuracy) of the C1INH function test. This study will also help to find out how many people who are thought to have HAE or who have family members with HAE actually get diagnosed and to gather participants' health background information, such as their age when they were diagnosed, what signs and symptoms they had, how long it took to get diagnosed, and how they were sent to the doctors or specialists who treated them.
During the study all participants will undergo two different methods of HAE testing: the test focusing on the C1INH function alone and the SoC tests. Test results will be confirmed via a second test run for newly index cases or for discordant results, but participants with a test result of "no HAE" and positive cases recruited through family screening will not undergo a second confirmatory test. In case of discordant test results in the second round, participants will undergo a third confirmatory test round. Participants can visit the clinic up to three times during the study. No further follow up is planned for participants, even for those who are diagnosed with HAE.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Suspected HAE Participants
Participants with suspected HAE having a high suspicion of bradykinin-mediated HAE (no urticaria or itching, lasting between 1 and 5 days, non-responsive to antihistamine and corticosteroid treatments) and/or family members of known HAE participants will be enrolled in the study.
Technochrom C1-INH Kit
HAE biological diagnostic test that uses functional C1-INH technique by colorimetric method versus the reference test defined as the SoC (C4 and C1-INH antigenic level measurement and functional C1-INH assay).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Technochrom C1-INH Kit
HAE biological diagnostic test that uses functional C1-INH technique by colorimetric method versus the reference test defined as the SoC (C4 and C1-INH antigenic level measurement and functional C1-INH assay).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participants providing a signed informed consent form (ICF), or parental consent for minors.
1. Participants with a high suspicion of bradykinin-mediated HAE, referred to the center. This includes recurrent episodes of nonpitting angioedema without urticaria or itching, lasting between 1 and 5 days, and non-responsive to antihistamine and corticosteroid treatments.
2. Family members (from 1st to 4th degree relatives) of known HAE participants.
Exclusion Criteria
2. Angioedema with urticaria or itching (suggesting histaminergic etiology).
3. Angioedema episodes lasting less than (\<)1 day or greater than (\>)5 days (not consistent with bradykinin-mediated HAE).
4. Any condition deemed unsuitable by the investigator that may interfere with study procedures or data integrity.
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CRO Axelys Santé DZ
UNKNOWN
Takeda
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for more information about this trial in easy-to-understand language.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TAK-743-4028
Identifier Type: -
Identifier Source: org_study_id