Please select the eligibility criteria that correspond to the clinical trial below.
Title: Icatibant Outcome Survey (IOS) Registry
Brief Summary: The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze® (C1 inhibitor \[human\]) in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr (icatibant) and Cinryze (C1 inhibitor \[human\]) in routine clinical practice and as a data source for post-marketing investigations.


Options:
A: Inclusion Criteria:

* At least 18 years of age at the time of screening
* Documented diagnosis of HAE (Type I or II)
* Experiencing ≥2 HAE attacks per year, with at least 1 attack in the past 6 months reported by the participant
* Willing and able to read, understand, and sign an informed consent form
* Females of childbearing potential must agree to be abstinent or else use acceptable forms of contraception throughout study
* Males with female partners of childbearing potential must agree to be abstinent or use a medically acceptable form of contraception throughout study

Exclusion Criteria:

* Exposure to an investigational drug or device within 90 days prior to study
* History of exposure within the past 5 years to a monoclonal antibody or recombinant protein bearing an Fc domain
* Concomitant diagnosis of another form of chronic angioedema
* Use of long-term prophylaxis for HAE within 90 days prior to study
* Use of C1-INH that exceeds a total of 30 days within the past 90 days prior to study; any use of C1-INH within 7 days prior to study
* Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption within 90 days prior to study
* Exposure to androgens within 90 days prior to study
* Presence of an indwelling catheter
* Diagnosis of HIV
* Active liver disease or liver function test abnormalities
* History of substance abuse or dependence
* Pregnancy or breastfeeding
* Any condition that, in the opinion of the Investigator, may compromise their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the results
B: Inclusion Criteria:

1. Diagnosis of at least 1 of the following:

   * Hereditary angioedema (HAE) type I or II
   * HAE with normal C1 inhibitor
   * ACE-I-induced angioedema
   * Non-histaminergic idiopathic angioedema
   * Acquired angioedema.
2. Signed and dated written informed consent from the participant or, for participants aged less than(\<)18 years (or as per local regulation, such as \<16 years in the United Kingdom \[UK\]), parent and/or participants legally authorized representative (LAR), and assent of the minor where applicable.
3. At sites only participating in the drug registry, participants must have taken at least 1 dose of Firazyr (Icatibant) or Cinryze (C1 inhibitor \[human\]).
4. Enrolled participants in Germany taking Firazyr (Icatibant) or Cinryze (C1 inhibitor \[human\]) will only use the respective product in accordance with the product label.

Exclusion Criteria:

1. Participants enrolled in clinical trials where the product is blinded or where the product under investigation is for the treatment of HAE, ACE-I-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema.
2. Participants enrolled in another Shire-sponsored registry involving products for the treatment of HAE, ACE-I-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema. An exception applies to participants enrolled in the Shire lanadelumab ENABLE study.
C: Key Inclusion Criteria:

* A clinical diagnosis of HAE type I or II
* Documented HAE attacks within a defined calendar period
* Access to acute attack medications
* Sexually active women of child-bearing potential and sexually active men must utilize effective contraception

Key Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Any clinical condition or medical history that would interfere with the subject's safety or ability to participate in the study
* Use of C1INH, androgens or tranexamic acid for prophylaxis of HAE attacks
* History of or current alcohol or drug abuse
* Infection with hepatitis B, hepatitis C or HIV
* Participation in any other investigational drug study currently or within the last 30 days
D: Key Inclusion Criteria:

1. A clinical diagnosis of HAE type I or II
2. Documented HAE attacks within a defined calendar period; in the absence of documented HAE attacks, subjects will be required to enter a run-in period to document attacks
3. Access to acute attack medications
4. Sexually active women of child-bearing potential and sexually active men must utilize highly effective contraception

Key Exclusion Criteria:

1. Women who are pregnant or breast-feeding
2. Any clinical condition or medical history that would interfere with the subject's safety or ability to participate in the study
3. Use of C1INH or tranexamic acid for prophylaxis of HAE attacks
4. Current participation in any other investigational drug study or within the last 30 days
5. History of or current alcohol or drug abuse
6. Infection with hepatitis B, hepatitis C or HIV

Answer: B