C1-Inhibitor Function Test to Diagnose HAE in Algeria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates how well a C1-inhibitor function test identifies HAE-C1INH-Type1 and HAE-C1INH-Type2 compared with standard clinical tests used in Algeria. The study uses the Technochrom C1-INH Kit to assess C1INH function and aims to establish a reference value for accuracy. It includes adults and children over 12 who have a high likelihood of bradykinin-mediated HAE or are family members of known HAE patients. Exclusion criteria remove those with confirmed HAE-Type1/Type2 or histaminergic angioedema, ensuring the focus remains on bradykinin-mediated disease. The investigation is sponsored by Takeda with Axelys Santé DZ and conducted at EPH de Rouiba in Algiers.

Why it matters

Who can join: the full rules

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.

Where it's running

• EPH de Rouiba (Etablissement Public Hospitalier)
  Algiers, Algeria Recruiting

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.