Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE

Inclusion criteria

• Males and females at least 18 years of age at the time of informed consent
• Documented diagnosis of hereditary angioedema Type I or II based on ALL of the following criteria:

• Family and/or medical history
• Characteristic attack manifestations, recurrent attacks
• Historical low C4, normal C1q and either low C1-INH or low C1INH function
• Women of childbearing potential must use consistently and correctly a highly effective, adequate method of birth control (failure rate less than 1% per year), sexual abstinence or have a vasectomised partner during the duration of the study. Hormonal contraception can be continued if verified by a physician that it doesn't affect the course of hereditary angioedema attacks.
• Mental and physical condition allowing patients to complete baseline assessment, to self-administer Icatibant and to follow other study procedures.
• Ability to provide signed written informed consent after all aspects of the study have been explained and discussed with the patient.

Exclusion criteria

• Participation in a clinical therapeutic trial of another investigational medicinal product within the past month (except a previous Icatibant study).
• Diagnosis of angioedema other than Type I or Type II hereditary angioedema.
• Evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease.
• Congestive heart failure (NYHA Class 3 and 4).
• Stroke within the past 6 months.
• Treatment with angiotensin converting enzyme inhibitor.
• Pregnancy and/or breast-feeding.
• In the opinion of the investigator: mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
• In the opinion of the investigator: unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason.
• In the opinion of the investigator: inability to complete the patient diary, manage study medication or self-administration of an injection.