A Prospective, Open-Label Study to Assess Functional C1-inhibitor Measurement for Diagnosing Hereditary Angioedema in Algeria

What this Trial Is About

Researchers are studying hereditary angioedema (HAE), a rare condition causing sudden swelling under the skin and inside the body, such as in the belly, throat, or genitals. This swelling is due to temporary blood vessel leakage and does not cause itching or hives. The study focuses on testing the effectiveness of measuring the function of a protein called C1-inhibitor (C1INH) alone to diagnose two types of HAE: HAE-C1INH-Type1 and HAE-C1INH-Type2, compared to the standard tests used in Algeria. The study also aims to establish a reference value for this test and collect health background information from participants. During the study, all participants will undergo two diagnostic methods: the new test measuring C1INH function alone (using the Technochrom C1-INH Kit) and the standard of care (SoC) tests, which include measuring C4 and C1-INH antigenic levels and function. For participants with new or conflicting test results, a second confirmatory test will be performed, and if needed, a third test. Participants suspected of HAE or family members of known HAE cases will be enrolled. They may visit the clinic up to three times, with no further follow-up planned after testing. Participants will provide health history data, including age at diagnosis, symptoms, diagnostic delays, and referral pathways. Researchers will measure the accuracy and reliability of the new test compared to standard methods. The main outcome is the sensitivity and specificity of the Technochrom test for diagnosing HAE. The study will last up to 12 months for each participant, with no additional long-term follow-up.

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