A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Icatibant
Intervention description: Participants will receive icatibant 30 mg SC injection in the abdominal area.
Intervention MeSH terms: Icatibant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the efficacy, pharmacokinetics (PK), and safety of
      icatibant for the treatment of acute attacks in Japanese participants with type I or type II
      hereditary angioedema (HAE).
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant is in Japan and is Japanese; defined as born in Japan and having
             Japanese parents and Japanese maternal and paternal grandparents.

          2. The participant is male or female and greater than or equal to (>=) 18 years of age at
             the time of informed consent.

          3. The participant has a confirmed diagnosis of hereditary angioedema (HAE) type I or II.
             Diagnosis may be based on historical data using the following criteria:

               1. Family history of angioedema

               2. Characteristic attack manifestations, recurrent attacks

               3. C1 esterase inhibitor (C1-INH) deficiency

               4. In the absence of a family history of angioedema, exclusion of other forms of
                  angioedema (example: acquired angioedema)

          4. If the participant does not have a confirmed diagnosis of HAE type I or II based on
             historical data, including C1-INH deficiency, the participant's diagnosis must be
             determined prior to treatment by C1-NH test results which demonstrate a quantitative
             and/or functional C1-INH deficiency.

               1. HAE type I: Low amount of C1-INH protein and low level of C1-INH activity; HAE
                  type; II: Normal or increased amount of C1-INH protein and low level of C1-INH
                  activity

               2. In the absence of a family history of angioedema, exclusion of other forms of
                  angioedema based on a normal level of C1q.

          5. The current HAE attack must be in the cutaneous, abdominal, and/or laryngeal
             (inclusive of laryngeal and pharyngeal) areas.

          6. The attack must be moderate to severe for non-laryngeal and mild to moderate for
             laryngeal as determined by investigator global assessment at pretreatment (baseline).

          7. The participant 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
             (h) after the onset of the attack. Note: for participant who present to the
             hospital/clinic with symptoms which have already progressed to at least moderate
             (non-laryngeal) or mild (laryngeal) severity, their duration can be estimated by the
             investigator through questioning of the participant.

          8. The participant (or the participant's parent/legal guardian, if applicable) has
             provided written informed consent which has been approved by the Institutional Review
             Board/Independent Ethics Committee (IRB/IEC).

               1. If the participant is an adult, be informed of the nature of the study and
                  provide written informed consent before any study-specific procedures are
                  performed. OR

               2. If the participant is a minor (that is [i.e.] < 20 years of age), have a
                  parent/legal guardian who is informed of the nature of the study provide written
                  informed consent (i.e., permission) for the minor to participate in the study
                  before any study-specific procedures are performed; Assent will be obtained from
                  minor participants.

          9. Females of childbearing potential must have a negative urine pregnancy test and must
             use medically acceptable methods to prevent pregnancy during their active
             participation in the study, (time from icatibant treatment of the acute attack to the
             follow-up visit at Day 7 [+3 days]), with the exception of those females who have had
             a total hysterectomy or bilateral oophorectomy, or who are 2 years post menopausal.

        Exclusion Criteria:

          1. The participant will require an intervention to support the airway (example:
             intubation, tracheotomy, cricothyrotomy) due to the current attack of angioedema.

          2. The participant presents with an HAE attack with laryngeal/upper respiratory tract
             symptoms which are considered severe in the investigator's clinical judgment and in
             conjunction with the investigator global assessment and which may necessitate urgent
             care and/or impede the conduct of study efficacy assessments.

          3. The participant has a diagnosis of angioedema other than HAE (non-hereditary
             angioedema, example: acquired angioedema).

          4. The participant has received previous treatment with icatibant.

          5. The participant is enrolled in another clinical study that involves investigation or
             use of any investigational product (drug or device) within 30 days prior to study
             enrollment or at any time during the study.

          6. The participant has received treatment with any pain medication since the onset of the
             current angioedema attack.

          7. The participant has received replacement therapy (C1-INH products, fresh frozen plasma
             [FFP]) < 5 days (120 hours) from the onset of the current angioedema attack.

          8. The participant is receiving treatment with angiotensin converting enzyme (ACE)
             inhibitors.

          9. The participant has evidence of coronary artery disease based on medical history at
             the screening examination or at pretreatment; example: unstable angina pectoris or
             severe coronary heart disease and congestive heart failure, that in the investigator's
             judgment would be a contraindication for participation in the trial (New York Heart
             Association [NYHA] class 3 and 4).

         10. The participant has a serious pre-existing condition or condition that, in the opinion
             of the investigator, would be a contraindication for participation in the trial.

         11. The participant is pregnant or breastfeeding.

         12. The participant is unable to understand the nature, scope, and possible consequences
             of the protocol, or is unlikely to comply with the protocol assessments, unable to
             return for follow up visits, or unlikely to complete the study for any reason.