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:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT07251933
Eligibility Criteria:
Inclusion Criteria:
1. Participant is aged 2 to less than (\<) 12 years at the time of lanadelumab initiation and is expected to have at least 6 months of follow-up information before turning 12.
2. Participant has physician-confirmed diagnosis of HAE-C1INH.
3. Participant initiated LTP with lanadelumab during the eligibility period.
4. Signed consent/assent (where required by local regulations).
5. Participant's medical record contains documentation of HAE attacks in the pre-index period and after lanadelumab initiation.
Exclusion Criteria:
1. Participant was enrolled in a therapeutic investigational drug (lanadelumab or other drug) or device trial at index date.
2. Participant with no documented HAE attacks in the 12 months prior to index date.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
11 Years
Study:
NCT07251933
Study Brief:
Protocol Section:
NCT07251933