A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt (EXPLORHAE)

Takeda

Status: Begins enrollment in 1 month

Conditions: Hereditary Angioedema (HAE)

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT07218393

TAK-743-4031

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

100 participants in 2 patient groups

Retrospective Phase

Description:

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.

Treatment:

Other: No intervention

Prospective Phase

Description:

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.

Treatment:

Other: No intervention