Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: DX-2930 - 300mg/2wk; DX-2930 - 300mg/4wk; DX-2930 - 150mg/4wk; Placebo
Intervention description: 300 mg DX-2930 administered every 2 weeks by subcutaneous injection.; 300 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.; 150 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.; Placebo administered every 2 weeks by subcutaneous injection.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: DX-2930; Hereditary Angioedema; Dyax

Summary:

      This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to
      evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in
      patients with Type I and Type II HAE.
    

Eligibility criteria:

        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.