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A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) in the Kingdom of Saudi Arabia

Recruitingn/aAges 12 Years - anyAllTakeda
NCT07263685 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 but does not cause itching or hives. HAE is classified based on the amount of a protein in the blood called C1 inhibitor (C1INH): HAE with normal C1INH levels (HAE-nC1INH) and HAE with limited or insufficient C1INH levels (HAE-C1INH); HAE-C1INH can be divided into Type 1, with low levels of C1INH, and Type 2, in which the protein is there, but does not work properly. This study will concentrate on people with HAE-C1INH Type 1 or 2 who have received Takhzyro® (lanadelumab) as prophylactic treatment for at least half a year (6 months). Prophylactic means that treatment is given to prevent the happening of HAE attacks. The main goal of the study is to see how well Takhzyro® w

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Participant is diagnosed with HAE-C1INH-Type 1 or HAE-C1INH-Type 2 and initiated on long-term prophylaxis (LTP) with Takhzyro® (lanadelumab). 2. Participant is aged greater than or equal to (\>=) 12 years at the time of Takhzyro® initiation. 3. Participant has received at least 6 months of continuous treatment with Takhzyro® before data abstraction. Exclusion Criteria: 1. Participants who have normal C1INH function or HAE-nC1INH (formerly type III HAE). 2. Participants who discontinued Takhzyro® before completing 6 months of treatment. 3. Participants with insufficient or incomplete medical records which prevent the assessment of baseline HAE-AS at the time of Takhzyro® initiation, as well as 6 months HAE-AS after treatment initiation. 4. Participants who are participating in an interventional clinical trial involving other HAE-C1INH treatments during the observation period.
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What it tests

  • No intervention
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Where

1 site
King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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