Hereditary Angioedema (HAE)EXPLORHAENCT07218393
A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt
An observational study of Hereditary Angioedema (HAE), run by Takeda at 7 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Hereditary Angioedema (HAE)
- How many people
- 100 participants
- Where
- 7 sitesEgypt
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Observational
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and pediatric participants with HAE-C1INH type1 or type2, treated within a routine clinical setting in Egypt.
Who may be able to join
- The participant has a confirmed HAE-C1INH type1 or type2 diagnosis in medical records (based on clinical history and/or laboratory diagnosis in medical records).
- The participant was diagnosed and/or treated from January 2015 to August 2025.
- The participant has a physician-confirmed HAE-C1INH type1 or type2 diagnosis (based on clinical history and/or laboratory diagnosis).
- The participant signed an informed consent or assent.
- The participant should have had at least one visit to the treating physician/investigator during enrollment and the follow-up period.
- The participant was not enrolled in the study's retrospective phase.
Show all 10Show fewer
- Exclusion Criteria: (For both retrospective and prospective phases):
- Participant with AAE-C1INH (acquired angioedema), drug-induced angioedema (AE-DI) (example angiotensin-converting enzyme inhibitors-I [ACE-I] angioedema), allergic mediated angioedema, inflammatory angioedema, or idiopathic angioedema.
- HAE participants with normal C1-INH (HAE-nC1INH).
- Participant deemed unsuitable for participation for any reason, based on the investigator's clinical judgment.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Egypt7 sites
Mansoura university hospital
Al Mansurah, 35511
Site Contact, (002)01066266746, besarmarwa@gmail.com
Marwa abo elmaaty
Alexandria university_Clinical Research Center
Alexandria, 21526
Site Contact, (002)01274476086, walaashoman@hotmail.com
Walaa Shoman
Ain shams university hospital_Pediatrics
Cairo, 11535
Site Contact, (002)01007448085, elham.hossny@gmail.com
Elham Hossny
Ain shams university hospital
Cairo, 11535
Site Contact, (002)01001525144, Dinasheha@med.asu.edu.eg
Dina Sheha
Cairo university hospital_Pediatrics
Giza, 11632
Site Contact, (002)01223985147, aisha_mars@hotmail.com
Aisha Elmarsafy
Cairo university hospital
Giza, 11632
Site Contact, (002)01001833370, nohakhalil78@hotmail.com
Noha Khalil
Zagazig university hospital
Zagazig, 44511
Site Contact, (002)01090419880, alqurashilobna@yahoo.com
Lobna Elkorashy
About this study
Official title: Retrospective and Prospective Real-World Evidence (RWE) Study Investigating Diagnosis and Therapeutic Management of Patients With HAE Type I or II in the Current Medical Practice in Egypt: the EXPLORHAE Study (EXPLORing Prospective and Retrospective Health Assessments of HAE in Egypt)
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. HAE is classified based on the amount of a protein in the blood called C1 inhibitor (C1-INH): HAE with normal C1-INH levels and HAE with limited or insufficient C1-INH levels (C1-INH deficiency); HAE with C1-INH deficiency can be divided into Type1, with low levels of C1-INH, and Type 2, in which the protein is there, but does not work properly. This study will look at people with HAE Type1 or Type2.
The main aim of this study is to describe the diagnosis and management of people with HAE Type1 or HAE Type2 in Egypt. Other aims are to learn more about people with HAE Type1 or Type2, including, but not limited to, other conditions they may have, family history, impact of HAE on daily life, if treatment is stopped and the reasons.
During the study, information from already existing data in a participant's medical record will be reviewed and new data will be collected during routine visits of a participant to the study clinic.
- Conditions
- Hereditary Angioedema (HAE)
- Being tested
- No intervention
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Phase | All participants who were diagnosed with HAE-C1INH type1 or type2 from January 2015 to August 2025; retrospective clinical data will be extracted for 5 months exclusively from patients' medical charts, and no direct patient interaction will occur. Receives: Other: No intervention | |
| Prospective Phase | All participants with any newly diagnosed or admitted or follow-up HAE-C1INH type1 or type2; prospective clinical data will be actively collected over 12 months through routine visits and electronic data capture (EDC) entries. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age of Participants at Diagnosis (in years) of HAE-C1INH Type1 or Type2
Measured: At Day 1
Percentage of Participants With HAE-C1INH Type1 or Type2
Measured: At Day 1
Number and Type of First Symptom at Initial Manifestation
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With First Symptom at Initial Manifestation
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Duration of First Symptom at Initial Manifestation
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number and Type of Confirmed Diagnosis of HAE-C1INH Type1 or Type2
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Confirmed Diagnosis of HAE-C1INH Type1 or Type2
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Duration of Confirmed Diagnosis of HAE-C1INH Type1 or Type2
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants with Recorded Diagnostic Test Results for C1-INH Antigenic Level, Serum Complement Component 4 (C4) Level, and C1-INH Functional Level
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants Receiving On-demand (OD), Short-term prophylaxis (STP), and Multiple Long-Term Prophylaxis (LTP) Therapies
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants who Received Prescriptions for Therapeutic Management With HAE-C1INH Type1 or Type2
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Treatment Options Used for the Therapeutic Management of Participants With HAE-C1INH Type1 or Type2
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Routes of Administration Used for the Therapeutic Management of Participants With HAE-C1INH Type1 or Type2
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Dose Regimens Used for the Therapeutic Management of Participants With HAE-C1INH Type1 or Type2
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants Switching Treatment for the Therapeutic Management of Participants With HAE-C1INH Type1 or Type2
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Frequency of Treatment Changes for the Therapeutic Management of Participants With HAE-C1INH Type1 or Type2
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Reason for Switching Treatment for the Therapeutic Management of Participants With HAE-C1INH Type1 or Type2
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Secondary outcomes (33)
Number of Participants With Clinical Symptoms of HAE-C1INH Type1 or Type2 at Last Clinical Appointment
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Clinical Symptom Types of HAE-C1INH Type1 or Type2 at Last Clinical Appointment
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Duration of Clinical Symptoms of HAE-C1INH Type1 or Type2 at Last Clinical Appointment
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Known Triggers at Diagnosis
Triggers include stress, trauma, infection, contraception, menstruation, medication, food, burns, surgical procedures, and others.
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With History of Upper Airway Edema
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With History of Abdominal Surgery due to HAE Misdiagnosis
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With HAE-related Death
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Response to Standard Allergy Medications
Standard allergy medications (e.g. antihistamines, glucocorticoids, and epinephrine) that will be reported based on the symptom improvement, time to relief, reduction in symptom severity, and need for additional interventions.
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Presence of Comorbidities
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Average Number of HAE Attacks per Month
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Average Number of Attacks Requiring Acute Treatment per Month
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Average Number of Attacks Requiring Emergency Care or Hospitalization per Month
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Severity of HAE Attack per Each Attack
Number of participants with severity of HAE attack (mild, moderate, severe as reported or documented) per each attack.
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Time of HAE Attack(s) at Each Onset During Follow-Up Visits or Date of Last Recorded HAE Attack
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Duration of Symptoms for Each HAE Attack Onset During Subsequent Follow-Up Visits
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of HAE Attacks per Month
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants Categorized by HAE Attack Characteristics
HAE attack characteristics will include most common attack site(s) (e.g., abdominal, cutaneous, laryngeal), number of recurrent abdominal attacks, site of attack per each attack onset for each subsequent follow-up visit, and symptoms experienced per attack (e.g., pain, swelling, nausea).
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Prodromal Symptom
Prodromal symptoms before attacks such as general discomfort, tiredness, irritability, skin symptoms, rash, and paresthesia per each attack onset for each subsequent follow-up visit will be reported.
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With any Known Triggers Identified by the Participant as Related to the Onset of the Attack per Each Attack Onset for Each Subsequent Follow-up Visits
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With On-demand Treatment Medication for Each HAE Attack
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number and Type of Hospitalizations due to HAE Attacks
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Life-threatening Attacks
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants (Family Members) Diagnosed With HAE-C1INH Type1 or Type2
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Degree of Relation (Parent, Sibling, Child) to Diagnosed Family Members
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Presence of Laryngeal or Life-threatening Attacks in Relatives
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Rate of Testing and of Diagnosis Among Tested Family Members
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With History of HAE-related Deaths in the Family
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participant's Relatives who Underwent Clinical and/or Lab Assessment for HAE diagnosis
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Clinical Assessment for HAE Diagnosis With Symptoms Description for the Patient, their Descendants, or Relatives
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Laboratory Testing for the Participant, Their Descendants, or Relatives
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Follow-up Visits Routinely Performed (Average per Year) During the Retrospective and Prospective Phase
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants Who Missed Days at Work or School and Social Life due to HAE Attack
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Treatment Discontinuation
Participants who discontinued the treatment due to reasons such as lack of efficacy, safety concerns, compliance issues, or others.
Measured: Up to 5 months retrospectively, up to 12 months prospectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218393
- Sponsor's protocol ID
- TAK-743-4031
- Acronym
- EXPLORHAE
- Status last verified
- Jun 2026
- First submitted
- 16 Oct 2025
- Last updated
- 18 Jun 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Real-World Evidence (RWE) Study Investigating Diagnosis and Therapeutic Management of Patients With HAE Type I or II in the Current Medical Practice in Egypt: the EXPLORHAE Study (EXPLORing Prospective and Retrospective Health Assessments of HAE in Egypt)
- ClinicalTrials.gov ID
- NCT07218393
- Acronym / sponsor ID
- EXPLORHAE / TAK-743-4031
- Conditions
- Hereditary Angioedema (HAE)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Oct 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. HAE is classified based on the amount of a protein in the blood called C1 inhibitor (C1-INH): HAE with normal C1-INH levels and HAE with limited or insufficient C1-INH levels (C1-INH deficiency); HAE with C1-INH deficiency can be divided into Type1, with low levels of C1-INH, and Type 2, in which the protein is there, but does not work properly. This study will look at people with HAE Type1 or Type2.
The main aim of this study is to describe the diagnosis and management of people with HAE Type1 or HAE Type2 in Egypt. Other aims are to learn more about people with HAE Type1 or Type2, including, but not limited to, other conditions they may have, family history, impact of HAE on daily life, if treatment is stopped and the reasons.
During the study, information from already existing data in a participant's medical record will be reviewed and new data will be collected during routine visits of a participant to the study clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Phase | – | Other: No interventionAll participants who were diagnosed with HAE-C1INH type1 or type2 from January 2015 to August 2025; retrospective clinical data will be extracted for 5 months exclusively from patients' medical charts, and no direct patient interaction will occur. |
| Prospective Phase | – | Other: No interventionAll participants with any newly diagnosed or admitted or follow-up HAE-C1INH type1 or type2; prospective clinical data will be actively collected over 12 months through routine visits and electronic data capture (EDC) entries. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric participants with HAE-C1INH type1 or type2, treated within a routine clinical setting in Egypt.
Key inclusion criteria (10 listed)
- The participant has a confirmed HAE-C1INH type1 or type2 diagnosis in medical records (based on clinical history and/or laboratory diagnosis in medical records).
- The participant was diagnosed and/or treated from January 2015 to August 2025.
- The participant has a physician-confirmed HAE-C1INH type1 or type2 diagnosis (based on clinical history and/or laboratory diagnosis).
- The participant signed an informed consent or assent.
- The participant should have had at least one visit to the treating physician/investigator during enrollment and the follow-up period.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| No interventionThis is a non-interventional study. | Other | Prospective Phase, Retrospective Phase |
Primary outcome
Age of Participants at Diagnosis (in years) of HAE-C1INH Type1 or Type2
Time frame: At Day 1
Percentage of Participants With HAE-C1INH Type1 or Type2
Time frame: At Day 1
Number and Type of First Symptom at Initial Manifestation
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With First Symptom at Initial Manifestation
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Duration of First Symptom at Initial Manifestation
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number and Type of Confirmed Diagnosis of HAE-C1INH Type1 or Type2
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Confirmed Diagnosis of HAE-C1INH Type1 or Type2
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Duration of Confirmed Diagnosis of HAE-C1INH Type1 or Type2
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants with Recorded Diagnostic Test Results for C1-INH Antigenic Level, Serum Complement Component 4 (C4) Level, and C1-INH Functional Level
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants Receiving On-demand (OD), Short-term prophylaxis (STP), and Multiple Long-Term Prophylaxis (LTP) Therapies
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants who Received Prescriptions for Therapeutic Management With HAE-C1INH Type1 or Type2
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Treatment Options Used for the Therapeutic Management of Participants With HAE-C1INH Type1 or Type2
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Routes of Administration Used for the Therapeutic Management of Participants With HAE-C1INH Type1 or Type2
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Dose Regimens Used for the Therapeutic Management of Participants With HAE-C1INH Type1 or Type2
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants Switching Treatment for the Therapeutic Management of Participants With HAE-C1INH Type1 or Type2
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Frequency of Treatment Changes for the Therapeutic Management of Participants With HAE-C1INH Type1 or Type2
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Reason for Switching Treatment for the Therapeutic Management of Participants With HAE-C1INH Type1 or Type2
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
33 secondary outcomes
Number of Participants With Clinical Symptoms of HAE-C1INH Type1 or Type2 at Last Clinical Appointment
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Clinical Symptom Types of HAE-C1INH Type1 or Type2 at Last Clinical Appointment
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Duration of Clinical Symptoms of HAE-C1INH Type1 or Type2 at Last Clinical Appointment
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Known Triggers at Diagnosis
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With History of Upper Airway Edema
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With History of Abdominal Surgery due to HAE Misdiagnosis
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With HAE-related Death
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Response to Standard Allergy Medications
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Presence of Comorbidities
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Average Number of HAE Attacks per Month
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Average Number of Attacks Requiring Acute Treatment per Month
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Average Number of Attacks Requiring Emergency Care or Hospitalization per Month
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Severity of HAE Attack per Each Attack
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Time of HAE Attack(s) at Each Onset During Follow-Up Visits or Date of Last Recorded HAE Attack
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Duration of Symptoms for Each HAE Attack Onset During Subsequent Follow-Up Visits
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of HAE Attacks per Month
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants Categorized by HAE Attack Characteristics
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Prodromal Symptom
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With any Known Triggers Identified by the Participant as Related to the Onset of the Attack per Each Attack Onset for Each Subsequent Follow-up Visits
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With On-demand Treatment Medication for Each HAE Attack
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number and Type of Hospitalizations due to HAE Attacks
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Life-threatening Attacks
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants (Family Members) Diagnosed With HAE-C1INH Type1 or Type2
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Degree of Relation (Parent, Sibling, Child) to Diagnosed Family Members
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Presence of Laryngeal or Life-threatening Attacks in Relatives
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Rate of Testing and of Diagnosis Among Tested Family Members
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With History of HAE-related Deaths in the Family
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participant's Relatives who Underwent Clinical and/or Lab Assessment for HAE diagnosis
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Clinical Assessment for HAE Diagnosis With Symptoms Description for the Patient, their Descendants, or Relatives
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Laboratory Testing for the Participant, Their Descendants, or Relatives
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Follow-up Visits Routinely Performed (Average per Year) During the Retrospective and Prospective Phase
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants Who Missed Days at Work or School and Social Life due to HAE Attack
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
Number of Participants With Treatment Discontinuation
Time frame: Up to 5 months retrospectively, up to 12 months prospectively
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 18 Jun 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.
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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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Angioedema (HAE), run by Takeda at 7 sites in Egypt.
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 10 inclusion and 0 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: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Egypt. 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?
Age of Participants at Diagnosis (in years) of HAE-C1INH Type1 or Type2 (time frame: At Day 1). The study lists 17 primary outcomes in all. 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 18 Jun 2026.