Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT05453968
Eligibility Criteria:
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 term oral 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 limit of the age-appropriate normal reference range value
* Clinically significant abnormal ECG including but not limited to, a corrected QT interval calculated using Fridericia's correction \> 450 msec, or ventricular and/or atrial premature contractions that are more frequent than occasional, and/or as couplets or higher in grouping
* Current participation in any other investigational drug study or received another investigational drug within 30 days of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
11 Years
Study:
NCT05453968
Study Brief:
Protocol Section:
NCT05453968