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A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema

RecruitingNAAges 12 Years - anyAllTakeda
NCT07293364 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Hereditary angioedema (HAE) is a rare condition. It causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. This swelling happens because of a temporary leak in blood vessels but does not cause itching or hives. HAE is classified based on the amount of a protein in the blood called C1-inhibitor (C1INH): HAE with normal C1INH levels and function (HAE-nC1INH) and HAE with deficiency in C1INH levels (HAE-C1INH-Type1) or dysfunction (HAE-C1INH-Type2). This study will focus on the practical use and accuracy of measuring the C1INH function alone to diagnose HAE-C1INH-Type1 and HAE-C1INH-Type2 compared to the tests used in normal clinical practice in Algeria. 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 o

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📋 Eligibility rules (as published)
Inclusion Criteria 1. Adult and pediatric participants of both sexes (children over the age of 12 years). 2. Participants providing a signed informed consent form (ICF), or parental consent for minors. 3. Participants should also meet one of the 2 inclusion criteria below: 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 1. Confirmed diagnosis of HAE-C1INH-Type1 or HAE-C1INH-Type2. 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.
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What it tests

  • Technochrom C1-INH Kit
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Where

1 site
EPH de Rouiba (Etablissement Public Hospitalier)
Algiers, Algeria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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