Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Icatibant
Intervention description: 30 mg subcutaneous dose of Icatibant
Intervention MeSH terms: Icatibant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators propose a study to evaluate the safety, local tolerability, convenience,
      and efficacy of self-administered Icatibant for the treatment of acute attacks of hereditary
      angioedema. The investigators believe that self administration with Icatibant for treatment
      of an acute attack of angioedema will not change the time to complete or near complete
      resolution of symptoms compared to treatment with Icatibant in a medical facility.
    

Eligibility criteria:

        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.