Hereditary Angioedema (HAE)AHAENCT07293364
A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema
A study testing Technochrom C1-INH Kit in people with Hereditary Angioedema (HAE), run by Takeda at 1 site in Algeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hereditary Angioedema (HAE)
- What is being tested?
- Technochrom C1-INH Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 1 siteAlgeria
- Study dates
- 12 May 2026to 12 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult and pediatric participants of both sexes (children over the age of 12 years).
- Participants providing a signed informed consent form (ICF), or parental consent for minors.
- Participants should also meet one of the 2 inclusion criteria below:
- 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.
- Family members (from 1st to 4th degree relatives) of known HAE participants.
Who cannot join
- Confirmed diagnosis of HAE-C1INH-Type1 or HAE-C1INH-Type2.
- Angioedema with urticaria or itching (suggesting histaminergic etiology).
- Angioedema episodes lasting less than (<)1 day or greater than (>)5 days (not consistent with bradykinin-mediated HAE).
- Any condition deemed unsuitable by the investigator that may interfere with study procedures or data integrity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Algeria1 site, 1 recruiting
- Recruiting
EPH de Rouiba (Etablissement Public Hospitalier)
Algiers, 16017
Site Contact, (213) 561073930, djenouhatkamel@gmail.com
Kamel Djenouhat
About this study
Official title: A Prospective, Open- Label, Single-country (Algeria), Interventional Study to Assess Measurements of Functional C1-inhibitor Alone for Hereditary Angioedema Diagnosis: The AHAE Study
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)
- Being tested
- Technochrom C1-INH Kit
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technochrom C1-INH KitDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Suspected HAE Participants | Experimental | 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. Receives: Diagnostic Test: Technochrom C1-INH Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Diagnostic Rate of Functional C1-INH Deficiency Using Technochrom in Highly Suspected Participants and Family Screening
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start12 May 2026
- Primary completion12 Jun 2027 (estimated)
- Study completion12 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Angioedema (HAE)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 514 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRO Axelys Santé DZ
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293364
- Sponsor's protocol ID
- TAK-743-4028
- Acronym
- AHAE
- Status last verified
- May 2026
- First submitted
- 8 Dec 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open- Label, Single-country (Algeria), Interventional Study to Assess Measurements of Functional C1-inhibitor Alone for Hereditary Angioedema Diagnosis: The AHAE Study
- ClinicalTrials.gov ID
- NCT07293364
- Acronym / sponsor ID
- AHAE / TAK-743-4028
- Conditions
- Hereditary Angioedema (HAE)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 514 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- CRO Axelys Santé DZ
- Study start
- 12 May 2026 (actual)
- Primary completion
- 12 Jun 2027 (estimated)
- Study completion
- 12 Jun 2027 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected HAE Participants | Experimental | Diagnostic Test: Technochrom C1-INH KitParticipants 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adult and pediatric participants of both sexes (children over the age of 12 years).
- Participants providing a signed informed consent form (ICF), or parental consent for minors.
- Participants should also meet one of the 2 inclusion criteria below:
Key exclusion criteria (4 listed)
- Confirmed diagnosis of HAE-C1INH-Type1 or HAE-C1INH-Type2.
- Angioedema with urticaria or itching (suggesting histaminergic etiology).
- Angioedema episodes lasting less than (<)1 day or greater than (>)5 days (not consistent with bradykinin-mediated HAE).
- Any condition deemed unsuitable by the investigator that may interfere with study procedures or data integrity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technochrom C1-INH KitHAE 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). | Diagnostic test | Suspected HAE Participants |
Primary outcome
Sensitivity and Specificity of Technochrom Compared to Standard of Care (SoC) for HAE Diagnosis
Time frame: Up to 12 months
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.
8 secondary outcomes
Laboratory-specific Cut-off Values for Functional C1-INH Measurement Using Technochrom
Time frame: Up to 12 months
Sensitivity and Specificity of Technochrom Compared to Isolated Complement Component Test (C4 assay) for HAE Detection
Time frame: Up to 12 months
Likelihood Ratios of Technochrom Compared to Isolated C4 Assay for HAE Detection
Time frame: Up to 12 months
Sensitivity and Specificity of Technochrom Compared to C4 Assay and C1-INH Antigenic Testing
Time frame: Up to 12 months
Likelihood Ratios of Technochrom Compared to C4 Assay and C1-INH Antigenic Testing
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
Time frame: Up to 12 months
Number of Participants Categorized by Their Epidemiological, Clinical and Biological Characteristics
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Hereditary Angioedema (HAE)
RecruitingObservational study
A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
Hereditary Angioedema (HAE)
Active, not recruitingPhase 3
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
Hereditary Angioedema
RecruitingPhase 3
Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks
Acute Hereditary Angio Edema
Active, not recruitingPhase 1/2
NTLA-2002 in Adults With Hereditary Angioedema (HAE)
Hereditary Angioedema
Enrolling by invitationPhase 3
Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
Hereditary Angioedema (HAE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technochrom C1-INH Kit in people with Hereditary Angioedema (HAE), run by Takeda at 1 site in Algeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of Technochrom Compared to Standard of Care (SoC) for HAE Diagnosis (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.