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 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT00097695
Eligibility Criteria:
Inclusion Criteria:
* Age above 18 years;
* Documented diagnosis of HAE Type I or II (confirmed complement 1 esterase inhibitor \[C1-INH\] deficiency);
* Current edema be in the cutaneous, abdominal and/or laryngeal areas;
* Current edema be moderate to severe according to the investigator's Symptom Score.
Exclusion Criteria:
* Diagnosis of angioedema other than HAE, for example, acquired angioedema (AAE);
* Participation in a clinical trial of another investigational medicinal product (IMP) within the past month;
* Treatment with any pain medication since onset of the current edema attack;
* Treatment with replacement therapy, including C1-INH products (e.g. human C1-INH preparations), less than 3 days from onset of the current edema attack;
* Treatment with ACE inhibitors (e.g. Lotensin, Prinivil, Accupril);
* Evidence of severe, symptomatic coronary artery disease based on medical history or screening examination;
* Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial;
* Pregnancy and/or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00097695
Study Brief:
Protocol Section:
NCT00097695