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 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT04739059
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged ≥ 12 years
* Diagnosed with clinically confirmed C1-INH HAE
* Experienced ≥ 3 HAE attacks during the 3 months before Screening
* Participated in the Run-in Period for at least 1 month (CSL312-naïve subjects only)
* Experienced at least an average of 1 HAE attack per month during the Run-in Period
Exclusion Criteria:
* Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria
* Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period
* Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
* Female subjects use estrogen-containing oral contraceptives or hormone replacement therapy within 4 weeks prior to screening
* Female or male subjects who are fertile and sexually active not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 30 days after receipt of the last dose of CSL312
* Pregnant, breastfeeding, or not willing to cease breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT04739059
Study Brief:
Protocol Section:
NCT04739059