C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema

Inclusion Criteria: Inclusion criteria for hereditary angioedema 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. Patients already using C1 inhibitor concentrate for prophylaxis of angioedema attacks. Age ≥ 16 years 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 Patient already using C1 inhibitor concentrate for prophylaxis of angioedema attacks Signed informed consent by patient and patient's legal representative if under 18 years old Exclusion Criteria: Exclusion criteria for hereditary angioedema patients: Use of angioedema prophylactic medication during the study, other than C1-esteraseremmer-N. Change in oral contraceptives starting from the last two months before the start of the trial until the end of the study period. Presence of clinically relevant 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 in part A of this protocol. Usage of heparin starting from the last two days prior to the study until the end of the study period. B-cell malignancy Pregnancy or lactation History of allergic reaction 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 Usage of heparin within the last two days prior to the study Pregnancy or lactation History of allergic reaction to C1 inhibitor concentrate or other blood products