A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Icatibant; Placebo
Intervention description: Single subcutaneous injection of icatibant, 30 mg; Single subcutaneous injection of matching placebo
Intervention MeSH terms: Icatibant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HAE; Type I HAE; Type II HAE

Summary:

      This study is being conducted to evaluate the efficacy and safety of icatibant compared to
      placebo in patients experiencing acute attacks of hereditary angioedema (HAE).
    

Eligibility criteria:

        Inclusion Criteria:

        Each patient must meet the following criteria to be enrolled in this study.

          1. The patient is ≥18 years old at the time of informed consent.

          2. The patient has a documented diagnosis of HAE type I or II. The diagnosis will be
             confirmed either by documented decreased C4 levels and/or immunogenic or functional
             C1-INH deficiency results (<50% of normal levels) consistent with HAE types I and II
             or by medical history.

          3. The current HAE attack must be in the cutaneous, abdominal and/or laryngeal (inclusive
             of laryngeal and pharyngeal) areas.

          4. Cutaneous or abdominal HAE attacks must be moderate to very severe as determined by
             investigator global assessment at pre-treatment assessments

          5. The patient must report at least 1 VAS score ≥ 30mm

          6. The patient commences treatment within 6 hours of the attack becoming at least mild
             (laryngeal) or moderate (non-laryngeal) in severity, but not more than 12 hours after
             the onset of the attack.

          7. Women of childbearing potential must have a negative urine pregnancy test and must use
             appropriate methods to prevent pregnancy during their participation in the study.

        Exclusion Criteria:

        Patients who meet any of the following criteria will be excluded from the study.

          1. The patient has a diagnosis of angioedema other than HAE type I or II.

          2. The patient has received previous treatment with icatibant.

          3. The patient has participated in a clinical trial and has received treatment with
             another investigational medicinal product within the past 30 days.

          4. The patient has received treatment with any pain medication since the onset of the
             current angioedema attack.

          5. The patient has received replacement therapy (fresh frozen plasma [FFP], C1-INH
             products) less than 5 days (120 hours) from the onset of the current angioedema
             attack.

          6. The patient is receiving treatment with angiotensin converting enzyme (ACE)
             inhibitors.

          7. Evidence of coronary artery disease based on medical history or screening examination
             in particular unstable angina pectoris or severe coronary heart disease;

          8. The patient has a serious concomitant illness or condition that, in the opinion of the
             Investigator, would be a contraindication for participation in the trial.

          9. The patient is pregnant or breastfeeding.