Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Ranging, Crossover Study to Evaluate the Safety and Efficacy of Subcutaneous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20) for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
Brief Summary: The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by subcutaneous (SC) injection to prevent angioedema attacks.


Options:
A: Inclusion Criteria:

- History of at least 1 HAE attack per month or any history of laryngeal edema

In addition, this study was open to all subjects who:

* Completed participation in LEVP2005-1/B (NCT01005888) any time after the final prophylactic therapy in Part B
* Were enrolled but not randomized in LEVP2005-1/A (NCT00289211) after Part A was closed
* Were enrolled and randomized in LEVP2005-1/A after LEVP2005-1/B was closed to enrollment, any time after the 3-day telephone follow-up
* Were excluded from LEVP2005-1 for any of the following reasons:

  * Pregnancy or lactation
  * Age less than 6 years
  * Narcotic addiction
  * Presence of anti-C1 inhibitor (C1INH) autoantibodies
* Were not enrolled in LEVP2005-1 after enrollment in LEVP2005-1 was closed, under the following circumstances:

  * Had a diagnosis of HAE: evidence of a low C4 level plus either a low C1INH antigenic level or a low C1INH functional level, or
  * Had a known HAE-causing C1INH mutation, or
  * Had a diagnosis of HAE based on a strong family history of HAE as determined by the principal investigator

Exclusion Criteria:

* History of allergic reaction to C1INH or other blood products
* Participated in any other investigational drug study within the past 30 days other than those sponsored by Lev Pharmaceuticals
* Received blood or a blood product in the past 60 days other than C1INH-nf
B: Inclusion Criteria:

* Documented HAE
* Normal C1q level

Exclusion Criteria:

* Low C1q level
* B-cell malignancy
* Presence of anti-C1INH autoantibody
* History of allergic reaction to C1INH or other blood products
* Narcotic addiction
* Current participation in any other investigational drug study or within the past 30 days
* Participation in a C1 esterase inhibitor trial, or received blood or a blood product in the past 90 days
* Pregnancy or lactation
* Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study
C: Inclusion Criteria:

* Be ≥12 years of age.
* Have a confirmed diagnosis of Hereditary Angioedema.

Exclusion Criteria:

* Receipt of any C1 inhibitor (C1 INH) therapy or any blood products for treatment or prevention of an angioedema attack within 7 days before the first dose of study drug.
* Be receiving prophylactic intravenous CINRYZE that exceeds 1000 units every 3 or 4 days (maximum weekly dose 2000 units).
* Have received any androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 7 days prior to the first dose of study drug.
* If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose of study drug.
* History of allergic reaction to C1 INH products, including CINRYZE or other blood products.
* History of abnormal blood clotting.
* Have a known allergy to hyaluronidase or any other ingredient in the study formulation.
D: 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

Answer: C