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for people ages 12 years and up (full criteria)
study started
estimated completion:



This study is an open-label, long term safety and efficacy study to evaluate DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.

Official Title

HELP Study ExtensionTM: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of DX-2930 for Prevention Against Acute Attacks of Hereditary Angioedema (HAE)


Hereditary Angioedema (HAE) DX-2930 Dyax Hereditary Angioedema Angioedema Angioedemas, Hereditary


You can join if…

Open to people ages 12 years and up

  • Male and female HAE subjects who are 12 years of age or older at the time of screening
  • Documented diagnosis of HAE, Type I or II
  • A historical baseline HAE attack rate of at least 1 attack per 12 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 has provided informed consent, are willing and able to read, understand and sign an assent form.
  • Males and females who are fertile and sexually active must adhere to contraception requirements for the duration of the study

You CAN'T join if...

  • Discontinued from DX-2930-03 after enrollment for any reason.
  • If rolling over from DX-2930-03, presence of important safety concerns that would preclude participation in this study.
  • Concomitant diagnosis of another form of chronic, recurrent angioedema, such as acquired angioedema (AAE), HAE with normal C1-INH (also known as HAE Type III),idiopathic angioedema, or recurrent angioedema associated with urticaria.
  • Dosing with an investigational drug (not including DX-2930 or other HAE therapies) or exposure to an investigational device within 4 weeks prior to screening.
  • Exposure to angiotensin-converting enzyme (ACE) inhibitors within 4 weeks prior to screening or any newly initiated or dose modification of estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) 3 months prior to the screening visit.
  • Unwilling to discontinue use of long-term prophylactic therapy for HAE (C1-INH,attenuated androgens, or anti-fibrinolytics) within 3 weeks after starting DX-2930 treatment.
  • 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.


  • University of California San Diego
    San Diego, California, 92122, United States
  • AIRE Medical of Los Angeles
    Santa Monica, California, 90404, United States
  • Allergy & Asthma Clinical Research
    Walnut Creek, California, 94598, United States


in progress, not accepting new patients
Start Date
Completion Date
Phase 3
Study Type
Last Updated
January 22, 2018