NCT07293364

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

A Prospective, Open- Label, Single-country (Algeria), Interventional Study to Assess Measurements of Functional C1-inhibitor Alone for Hereditary Angioedema Diagnosis: The AHAE Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 514 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Hereditary Angioedema (HAE)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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).

Timeline

• Start date: 2026-05-15
• Primary completion: 2027-01-07
• Completion: 2027-01-07
• First posted: 2025-12-19
• Last updated: 2026-04-01

Locations

1 site across 1 country: Algeria