This clinical trial is focused on studying a condition called Hereditary Angioedema (HAE), which is a rare genetic disorder that causes sudden swelling in various parts of the body. The study is testing a medication called Berotralstat, which is taken orally to help prevent these swelling attacks. The medication is available in two forms: hard capsules known as Orladeyo 150 mg and granules, both containing the active substance Berotralstat. The purpose of the study is to evaluate the safety and how the body processes this medication in children aged 2 to less than 12 years who have HAE.
Participants in the study will take Berotralstat over a period of time, and researchers will monitor them to see how the medication affects their bodies and if it helps reduce the frequency and severity of HAE attacks. The study will also look at any side effects that may occur. The medication is taken by mouth, and the study will last for a maximum of 144 weeks. During this time, researchers will collect information on the number of HAE attacks, how long they last, and any other related symptoms.
The study aims to provide valuable information on the use of Berotralstat in young children with HAE, helping to understand its potential benefits and any risks involved. This information could be important for developing better treatment options for children with this condition in the future.



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