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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-03-15

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hereditary Angioedema (HAE)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

No intervention

Intervention Type OTHER

This is a non-interventional study.

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.

No intervention

Intervention Type OTHER

This is a non-interventional study.

Interventions

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No intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

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

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.

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Retrospective Phase

No intervention

Prospective Phase

No intervention

Interventions

No intervention

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Takeda

Responsible Party

Principal Investigators

Study Director

Locations

Mansoura university hospital

Alexandria university_Clinical Research Center

Ain shams university hospital_Pediatrics

Ain shams university hospital

Cairo university hospital_Pediatrics

Cairo university hospital

Zagazig university hospital

Countries

Central Contacts

Takeda Contact

Facility Contacts

Site Contact

Site Contact

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Related Links

Other Identifiers

TAK-743-4031