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:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT00748202
Eligibility Criteria:
Inclusion Criteria:
* Subjects with an established diagnosis of HAE type I (C1-Inhibitor activity \< 50% and C1-Inhibitor antigen \< 15.4 mg/dl) or HAE type II (C1-Inhibitor activity \< 50% and C1-Inhibitor antigen in normal or elevated concentration of dysfunctional protein).
* Male and female subjects with an age of at least 18 years.
* Subjects providing an informed consent.
Exclusion Criteria:
* Subjects without an established diagnosis of HAE.
* Last C1-INH administration less than 7 days ago and/or acute attack.
* Subjects with acquired angioedema (AAE).
* All other types of angioedema not associated with C1-INH deficiency.
* Treatment with any investigational drug (exclusive drugs appropriate for the treatment of acute angioedema) 30 days before study treatment.
* Treatment with any other drug appropriate for the treatment of acute angioedema within 7 days before start of study treatment at each phase.
* Danazol prophylaxis.
* Prophylaxis with antifibrinolytics, EACA, tranexamic acid.
* Subjects with a known hypersensitivity to study medication (Berinert P).
* Pregnant women (pregnancy rapid assay required for women with childbearing potential), women currently breast-feeding, or with the intention to breast-feed
* Subjects with malignant diseases.
* Subjects with immunodeficiencies such as established acquired immunodeficiency syndrome.
* Subjects with concurrent serious or acute illness or infection as per investigators judgement.
* Subjects with mental conditions which render the subject or its legally acceptable representative unable to understand the nature, scope and possible consequences of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00748202
Study Brief:
Protocol Section:
NCT00748202