Berotralstat Treatment in Children With Hereditary Angioedema

Inclusion Criteria:

• Male and non-pregnant, non-lactating females 2 to < 12 years of age

• Body weight ≥ 12 kg

• Clinical diagnosis of HAE

• In the opinion of the investigator, the participant would benefit from long termoral HAE prophylaxis

Exclusion Criteria:

• Concurrent diagnosis of any other type of recurrent angioedema

• Known family history of sudden cardiac death

• Creatinine clearance using the modified Schwartz formula of ≤ 30 mL/min/1.73 m2

• Aspartate aminotransferase or alanine aminotransferase value ≥ 3 × the upper limitof the age-appropriate normal reference range value

• Clinically significant abnormal ECG including but not limited to, a corrected QTinterval calculated using Fridericia's correction > 450 msec, or ventricular and/oratrial premature contractions that are more frequent than occasional, and/or ascouplets or higher in grouping

• Current participation in any other investigational drug study or received anotherinvestigational drug within 30 days of enrollment