EASSI - Evaluation of the Safety of Self-Administration With Icatibant
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Icatibant
Intervention description: Single subcutaneous injection of icatibant, 30 mg
Intervention MeSH terms: Icatibant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HAE; Type I HAE; Type II HAE

Summary:

      This study is being conducted to explore the clinical safety, local tolerability, convenience
      and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous
      injections of icatibant.
    

Eligibility criteria:

        Inclusion Criteria:

        Each patient must meet the following criteria to be enrolled in this study.

          1. Males and females 18 years of age at the time of informed consent

          2. Documented diagnosis of HAE Type I or II based on ALL of the following criteria:

               -  Family and/or medical history

               -  Characteristic attack manifestations, recurrent attacks

               -  Historical functional C1-INH <50% normal values

          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 HAE 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:

        Patients who meet any of the following criteria will be excluded from the study.

          1. Participation in a clinical 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 HAE.

          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 (ACE) 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 manage study medication or
             self-administration of an injection.