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NCT Number: NCT07218393

A Study About the Diagnosis and Management of Hereditary Angioedema (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.

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Key information

Conditions

Hereditary Angioedema (HAE) Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura university hospital, Al Mansurah, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Retrospective Phase:

  • 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.

Inclusion criteria

Prospective Phase:

  • 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.

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.

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

  1. Age of Participants at Diagnosis (in years) of HAE-C1INH Type1 or Type2

    Time frame: At Day 1

  2. Percentage of Participants With HAE-C1INH Type1 or Type2

    Time frame: At Day 1

  3. Number and Type of First Symptom at Initial Manifestation

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  4. Number of Participants With First Symptom at Initial Manifestation

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  5. Duration of First Symptom at Initial Manifestation

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  6. Number and Type of Confirmed Diagnosis of HAE-C1INH Type1 or Type2

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  7. Number of Participants With Confirmed Diagnosis of HAE-C1INH Type1 or Type2

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  8. Duration of Confirmed Diagnosis of HAE-C1INH Type1 or Type2

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Number of Participants With Known Triggers at Diagnosis

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

    Triggers include stress, trauma, infection, contraception, menstruation, medication, food, burns, surgical procedures, and others.

  5. Number of Participants With History of Upper Airway Edema

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  6. Number of Participants With History of Abdominal Surgery due to HAE Misdiagnosis

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  7. Number of Participants With HAE-related Death

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  8. Number of Participants With Response to Standard Allergy Medications

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

    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.

  9. Number of Participants With Presence of Comorbidities

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  10. Average Number of HAE Attacks per Month

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  11. Average Number of Attacks Requiring Acute Treatment per Month

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  12. Average Number of Attacks Requiring Emergency Care or Hospitalization per Month

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  13. Number of Participants With Severity of HAE Attack per Each Attack

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

    Number of participants with severity of HAE attack (mild, moderate, severe as reported or documented) per each attack.

  14. 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

  15. 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

  16. Number of HAE Attacks per Month

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  17. Number of Participants Categorized by HAE Attack Characteristics

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

    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).

  18. Number of Participants With Prodromal Symptom

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

    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.

  19. 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

  20. Number of Participants With On-demand Treatment Medication for Each HAE Attack

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  21. Number and Type of Hospitalizations due to HAE Attacks

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  22. Number of Participants With Life-threatening Attacks

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  23. Number of Participants (Family Members) Diagnosed With HAE-C1INH Type1 or Type2

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  24. 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

  25. 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

  26. 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

  27. Number of Participants With History of HAE-related Deaths in the Family

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. Number of Participants With Treatment Discontinuation

    Time frame: Up to 5 months retrospectively, up to 12 months prospectively

    Participants who discontinued the treatment due to reasons such as lack of efficacy, safety concerns, compliance issues, or others.

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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)

Acronym: EXPLORHAE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 20, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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