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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT05833620
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (≥ 18 years old) with HAE-C1INH diagnosis (confirmed by mutation in SERPING1 gen or immunochemical study showing a decrease in C1INH function \<50% in two determinations together with a family history (symptomatic patients' group)
* Patients ≥ 22 years old with C1INH hereditary deficiency (confirmed by mutation of SERPING1 gene or immunochemical study showing a decrease in C1INH function \<50% in two determinations together with a family history) and who have not developed symptoms consistent with HAE-C1INH
* Signed informed consent.
Exclusion Criteria:
* No confirmed C1INH deficiency.
* Inability to sign the informed consent.
* Presence of recurrent angioedema with histaminergic characteristics (response to treatment with antihistamines, glucocorticoids and/or epinephrine)
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05833620
Study Brief:
Protocol Section:
NCT05833620