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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT00125151
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for HAE type I and type II patients:
* Established diagnosis of hereditary angioedema (type I or II): markedly decreased C1 inhibitor activity; decreased (type I), normal or elevated (type II) level of C1 inhibitor antigen; decreased level of C4.
* Age ≥ 16 years
* Evidence of a peripheral, abdominal, facial, laryngeal or genitourinary attack of angioedema of moderate to severe intensity, starting less then 5 hours before infusion. An attack is defined as moderate if it affects the normal daily activities of the patient in any way. Severe attacks are defined by the inability to perform normal daily activities.
* Signed informed consent by patient and patient's legal representative if under 18 years old
Inclusion criteria for acquired angioedema patients:
* Established diagnosis of acquired angioedema: recurrent attacks of angioedema without urticaria; no family history; decreased functional C1 inhibitor; decreased level of C4.
* Autoantibodies to C1 inhibitor or decreased C1q or onset after the third decade of life.
* Age ≥ 16 years
* Evidence of a peripheral, abdominal, facial, laryngeal or genitourinary attack of angioedema of moderate to severe intensity, starting less then 5 hours before infusion. An attack is defined as moderate if it affects the normal daily activities of the patient in any way. Severe attacks are defined by the inability to perform normal daily activities.
* Currently treated with C1 inhibitor concentrate to reverse angioedema.
* Signed informed consent by patient and patient's legal representative if under 18 years old
Exclusion Criteria:
Exclusion criteria for HAE type I and type II patients:
* Presence of clinically-relevant anti-C1 inhibitor auto-antibodies
* Participation in another pharmaceutical clinical study, which can interfere with this study, in the last 3 months prior to the study, other than Part A of this protocol.
* Addiction to narcotic/pain medication in case of an abdominal attack
* B-cell malignancy
* Use of narcotic medication within 3 days prior to attack.
* Use of heparin within the last two days prior to the study
* Pregnancy or lactation
* History of allergic reactions to C1 inhibitor concentrate or other blood products
Exclusion criteria for acquired angioedema patients:
* Participation in another pharmaceutical clinical study, which can interfere with this study, in the last 3 months prior to the study
* Addiction to narcotic/pain medication in case of an abdominal attack
* Use of narcotic medication within 3 days prior to attack.
* Use of heparin within the last two days prior to the study
* Pregnancy or lactation.
* History of allergic reactions to C1 inhibitor concentrate or other blood products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00125151
Study Brief:
Protocol Section:
NCT00125151