Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Two-period, Three-sequence, Partial Crossover Study to Evaluate the Efficacy and Safety of Subcutaneous Administration of 2000 IU of C1 Esterase Inhibitor [Human] Liquid for Injection for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
Brief Summary: The purpose of this study is to assess the efficacy and safety of subcutaneous administration of a liquid formulation of C1 esterase inhibitor for the prevention of angioedema attacks in adolescent and adult subjects with hereditary angioedema.


Options:
A: The maximum duration of participation is approximately 9 months. Patients will complete a screening period of up to 21 days. Following screening, eligible patients will be randomly assigned to 1 of 3 treatment sequences. Each patient will undergo 2 14-week treatment periods for a total of 28 weeks (Treatment Period 1 and Treatment Period 2). After completing the 2 treatment periods, patients will enter a 1-month follow-up period.
B: 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
C: Key Inclusion Criteria:

* A clinical diagnosis of hereditary angioedema Type 1 or Type 2, defined as having a C1-INH functional level and a C4 level below the lower limit of the normal (LLN) reference range, as assessed during the Screening period.
* Subject weight of ≥ 40 kg
* Access to and ability to use one or more acute medications approved by the relevant competent authority for the treatment of acute attacks of HAE
* Subjects must be medically appropriate for on-demand treatment as the sole medicinal management for their HAE during the study.
* Subjects must have a specified number of investigator-confirmed attacks during the run-in period of a maximum of 56 days from the Screening visit.
* Acceptable effective contraception
* Written informed consent

Key Exclusion Criteria:

* Pregnancy or breast-feeding
* Any clinically significant medical condition or medical history that, in the opinion of the Investigator or Sponsor, would interfere with the subject's safety or ability to participate in the study
* Any laboratory parameter abnormality that, in the opinion of the Investigator, is clinically significant and relevant for this study
* Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology
* Use of C1-INH within 14 days or use of androgens or tranexamic acid within 28 days prior to the Screening visit for prophylaxis of HAE attacks, or initiation of these drugs during the study
* Current participation in any other investigational drug study or received another investigational drug within 30 days of the Screening visit
* Prior enrollment in a BCX7353 study
D: Inclusion Criteria:

* Males and females 12 years of age or older at time of screening
* Documented diagnosis of HAE, Type I or II
* Baseline rate of at least 1 Investigator-confirmed HAE attack per 4 weeks
* Adult subjects and caregivers of subjects under the age of 18 are willing and able to read, understand, and sign an informed consent form. Subjects age 12 to 17, whose caregiver provides informed consent, are willing and able to read, understand an dsign an assent form.
* Males and femailes who are fertile and sexually active must adhere to contraception requirements.

Exclusion Criteria:

* Concomitant diagnosis of another form of chronic, recurrent angioedema, such as acquired angioedema, idiopathic angioedema, or recurrent angioedema associated with urticaria.
* Participation in a prior DX-2930 study
* Treatment with any other investigational drug or exposure to an investigational device within 4 weeks prior screening
* Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications within 4 weeks prior to screening.
* Exposure to androgens within 2 weeks prior to entering the run-in period.
* Use of long-term prophylactic therapy for HAE within 2 weeks prior to entering the run-in period.
* Use of short-term prophylaxis for HAE within 7 days prior to entering the run-in period.
* Any of the following liver function test abnormalities: alanine aminotransferase (ALT) \> 3x upper limit of normal, or aspartate aminotransferase (AST) \> 3x upper limit of normal, or total bilirubin \> 2x upper limit of normal (unless the bilirubin elevation is a result of Gilbert's syndrome).
* Pregnancy or breastfeeding.

Answer: A