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ClinicalTrials.gov ID

NCT07218393

Lead Sponsor

TakedaINDUSTRY

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

100Estimated

Last Update Posted

Jun 18, 2026Actual

Start Date

Dec 1, 2026Estimated

Primary Completion Date

Dec 1, 2027Estimated

Completion Date

Dec 1, 2027Estimated

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)

Brief 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. 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.

• Hereditary Angioedema (HAE)

• No intervention

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Retrospective Phase:

1. 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).
2. The participant was diagnosed and/or treated from January 2015 to August 2025.

Inclusion Criteria: Prospective Phase:

1. The participant has a physician-confirmed HAE-C1INH type1 or type2 diagnosis (based on clinical history and/or laboratory diagnosis).
2. The participant signed an informed consent or assent.
3. The participant should have had at least one visit to the treating physician/investigator during enrollment and the follow-up period.
4. The participant was not enrolled in the study's retrospective phase.

Exclusion Criteria: (For both retrospective and prospective phases):

1. 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.
2. HAE participants with normal C1-INH (HAE-nC1INH).
3. Participant deemed unsuitable for participation for any reason, based on the investigator's clinical judgment.

Observational Model

Cohort

Time Perspective

Other

Lead Sponsor

TakedaINDUSTRY

elham.hossny@gmail.com(002)01007448085

Dinasheha@med.asu.edu.eg(002)01001525144

aisha_mars@hotmail.com(002)01223985147

nohakhalil78@hotmail.com(002)01001833370

alqurashilobna@yahoo.com(002)01090419880