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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT01151735
Eligibility Criteria:
Inclusion Criteria:
1. Documented HAE type 1 or 2 by C4 level and C1-INH level or function.
2. Able to read, understand, and sign informed consent.
3. Above the age of 12 years.
4. Willing to complete daily diary.
5. Have at least 1 HAE exacerbations per month averaged over the last 6 months.
6. Prodromal symptoms will not be an inclusion or exclusion since if used it would bias our ability to determine specificity and sensitivity of prodromal symptoms.
7. Present for treatment within 6 hours of onset of prodromal symptoms.
8. Treatment for an acute attack can be given at any time without restriction.
Exclusion Criteria:
1. Inability to read English.
2. Prior adverse effects to C1-INH.
3. Participation in alternate investigational drug trial.
4. Diabetes, neurologic diseases, cardiac diseases, dermatologic diseases that may have associated symptoms that mimic prodromal symptoms.
5. Inability to withdraw from androgens or C1-INH prophylaxis.
6. Pregnant or breast feeding mothers.
7. Prisoners or other institutionalized individuals.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01151735
Study Brief:
Protocol Section:
NCT01151735