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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorTakeda

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adult and pediatric participants with HAE-C1INH type1 or type2, treated within a routine clinical setting in Egypt.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • No intervention

    Other intervention

    This is a non-interventional study.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Retrospective Phase1 intervention
Group B: Prospective Phase1 intervention

Trial outcomes

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

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

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

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

Other outcomes

Sponsors and contacts

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