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 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT01036659
Eligibility Criteria:
Inclusion Criteria:
1. Males and females of any race or ethnicity 18 or older. The locations of the study will permit all racial and ethnic distribution in the study
2. Must currently be on an ACE inhibitor
3. Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF
4. All females of childbearing age must have a negative pregnancy test prior to administration of the study drug.
Exclusion Criteria:
1. Participation in another investigational study within 30 days prior to enrollment
2. Patients who improve on conventional (standard of care) therapy
3. Patients previously treated with ecallantide
4. Hypersensitivity to ecallantide
5. Pregnancy or breast feeding
6. Other definable causes of angioedema (i.e., hereditary or acquired angioedema)
7. Patients receiving C-1 inhibitor as prophylaxis
8. Treatment requiring tranexamic acid, and epsilon-aminocaproic acid
9. Receiving fresh frozen plasma within 3 days prior to enrollment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01036659
Study Brief:
Protocol Section:
NCT01036659