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 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT04428632
Eligibility Criteria:
Inclusion Criteria
Patients must meet all of the following inclusion criteria to be eligible for participation in this program:
1. At least 12 years of age
2. Able to provide written, informed consent or assent
3. Patients with a clinical diagnosis of HAE Type I or II who, in the opinion of their treating physician, are expected to benefit from an oral treatment for the prevention of angioedema attacks, and who are not eligible or able to access a berotralstat clinical trial
4. Females must use acceptable effective contraception
Exclusion Criteria
Patients must meet none of the below exclusion criteria to be eligible for participation in this program:
1. Pregnancy or breast-feeding
2. Any clinically significant medical condition or medical history that, in the opinion of the treating physician, would interfere with the patient's safety
3. Current infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT04428632
Study Brief:
Protocol Section:
NCT04428632