An interventional study of Technochrom C1-INH Kit in Hereditary Angioedema (HAE), sponsored by Takeda. Recruiting at 1 site in Algeria. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Takeda · Not applicable, Interventional, and Diagnostic
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.
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
This study's planned enrollment of 514 is above the median of 48 across 116 interventional studies indexed under Angioedemas, Hereditary.
Browse Angioedemas, Hereditary studies →Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.
Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.
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Participants should also meet one of the 2 inclusion criteria below:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
Sensitivity and Specificity of Technochrom Compared to Standard of Care (SoC) for HAE Diagnosis
The diagnostic accuracy of isolated functional C1-inhibitor (C1-INH) measurement using Technochrom C1-INH kits, compared to the SoC (McNemar's test) as confirmatory testing for HAE diagnosis will be reported.
Time frame: Up to 12 months
Laboratory-specific Cut-off Values for Functional C1-INH Measurement Using Technochrom
Laboratory-specific cut-off values for functional C1-INH measurement in the Algerian population using the Technochrom C1-INH kit and assess their impact on diagnostic accuracy will be reported.
Time frame: Up to 12 months
Sensitivity and Specificity of Technochrom Compared to Isolated Complement Component Test (C4 assay) for HAE Detection
Sensitivity and specificity of Technochrom compared to isolated C4 assay will be evaluated.
Time frame: Up to 12 months
Likelihood Ratios of Technochrom Compared to Isolated C4 Assay for HAE Detection
Positive and negative likelihood ratios of the Technochrom compared to isolated measurement of antigenic C4 assay will be evaluated.
Time frame: Up to 12 months
Sensitivity and Specificity of Technochrom Compared to C4 Assay and C1-INH Antigenic Testing
Sensitivity and specificity of Technochrom compared to C4 assay and C1-INH antigenic testing will be evaluated.
Time frame: Up to 12 months
Likelihood Ratios of Technochrom Compared to C4 Assay and C1-INH Antigenic Testing
Positive and negative likelihood ratios of the Technochrom compared to C4 and C1-INH antigenic testing will be evaluated.
Time frame: Up to 12 months
Diagnostic Performance of Technochrom in Detecting Functional C1-INH Deficiency and its Impact on Accuracy and Reliability in Clinical Practice
Diagnostic performance assessment of Technochrom in detecting functional C1-INH deficiency, including its potential to enhance accuracy and reliability in clinical practice will be reported.
Time frame: Up to 12 months
Number of Participants Categorized by Their Epidemiological, Clinical and Biological Characteristics
Epidemiological, clinical, and biological characteristics of participants, including age at diagnosis, clinical presentation, diagnostic delay, and referral pathways will be reported.
Time frame: Up to 12 months
Diagnostic Rate of Functional C1-INH Deficiency Using Technochrom in Highly Suspected Participants and Family Screening
Time frame: Up to 12 months
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
Started May 2026 (actual). Primary completion is estimated for Jun 2027, 13 months after the start.
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