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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT01359969
Eligibility Criteria:
Inclusion Criteria:
* From 2 up to and including 13 years of age
* Clinical and laboratory confirmed diagnosis of HAE (baseline C1INH activity \<50% of normal)
* Signed written Informed Consent Form (ICF)(parental permission) signed by the legal guardian(s)
* Clinical symptoms of an acute HAE attack
* Onset of eligible symptoms within 5 hours from the moment at which medical evaluation to determine eligibility has occurred
* Attack severity moderate or greater, as rated by the investigator
Exclusion Criteria:
* A diagnosis of acquired C1INH deficiency (AAE)
* A medical history of allergy to rabbits or rabbit-derived products or positive anti-rabbit epithelium (dander) immunoglobuline E (IgE) test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
13 Years
Study:
NCT01359969
Study Brief:
Protocol Section:
NCT01359969