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Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE

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Disease Information

Descriptive Information
Brief Title † Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
Official Title † HELP Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate DX-2930 For Long-Term Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE)
Brief 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.
Detailed Description
Study Phase Phase 3
Study Type † Interventional
Study Design †
Primary Outcome Measure † Number of Investigator confirmed HAE attacks per week observed in each DX-2930 treatment arm versus placebo arm
Secondary Outcome Measure † Number per week of HAE attacks requiring acute attack therapy use for each DX-2930 treatment arm versus placebo arm
Condition † Hereditary Angioedema
Intervention † DrugDX-2930 - 300mg/2wk
Study Arms / Comparison Groups DX-2930 300 mg every 2 weeks 300 mg DX-2930 administered every 2 weeks by subcutaneous injection. DX-2930 300 mg every 4 weeks 300 mg DX-2930 administered every 4 weeks by subcutaneous injection DX-2930 150 mg every 4 weeks 150 mg DX-2930 administered every 4 weeks by subcutaneous injection Placebo Placebo administered every 2 weeks by subcutaneous injection.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 120
Start Date † March 3, 2016
Completion Date April 13, 2017
Primary Completion Date April 13, 2017
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.
Gender All
Ages 12 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Canada
Administrative Information
NCT ID † NCT02586805
Organization ID DX-2930-03
Secondary IDs †† 2015-003943-20
Responsible Party Sponsor
Study Sponsor † Shire
Collaborators †† Dyax Corp.
Investigators † Study Director: Shire Physician, Shire
Information Provided By
Verification Date May 2017
First Received Date † October 23, 2015
Last Updated Date May 23, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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