Efficacy, Safety and Tolerability of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema

Inclusion Criteria:

1. Males and females at least 18 years of age at the time of informed consent

2. 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

3. 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.

4. Mental and physical condition allowing patients to complete baseline assessment, to
self-administer Icatibant and to follow other study procedures.

5. Ability to provide signed written informed consent after all aspects of the study
have been explained and discussed with the patient.

Exclusion Criteria:

1. Participation in a clinical therapeutic trial of another investigational medicinal
product within the past month (except a previous Icatibant study).

2. Diagnosis of angioedema other than Type I or Type II hereditary angioedema.

3. Evidence of symptomatic coronary artery disease based on medical history, in
particular, unstable angina pectoris or severe coronary heart disease.

4. Congestive heart failure (NYHA Class 3 and 4).

5. Stroke within the past 6 months.

6. Treatment with angiotensin converting enzyme inhibitor.

7. Pregnancy and/or breast-feeding.

8. In the opinion of the investigator: mental condition rendering the patient unable to
understand the nature, scope and possible consequences of the study.

9. 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.

10. In the opinion of the investigator: inability to complete the patient diary, manage
study medication or self-administration of an injection.