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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hereditary Angioedema (HAE)

In brief

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.

Key facts

Study ID

NCT02586805

Run by

Shire

People needed

125

Starts

2016-03-03

Expected to finish

2017-04-13

Last updated by the study team

2021-06-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Research Center of Alabama, LLC — Birmingham, Alabama, United States
• Medical Research of Arizona — Scottsdale, Arizona, United States
• UC San Diego School of Medicine — San Diego, California, United States
• AIRE Medical of Los Angeles — Santa Monica, California, United States
• Allergy & Asthma Clinical Research — Walnut Creek, California, United States
• IMMUNOe International Health & Research Centers — Centennial, Colorado, United States
• Asthma and Allergy Associates, P.C. — Colorado Springs, Colorado, United States
• University of South Florida — Tampa, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Institute of Asthma & Allergy, P.C. — Chevy Chase, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan Hospital and Health System — Ann Arbor, Michigan, United States
• Midwest Immunology Clinic — Plymouth, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Hudson-Essex Allergy, LLC — Belleville, New Jersey, United States
• Atlantic Research Center, LLC — Ocean City, New Jersey, United States
• Winthrop University Hospital — Mineola, New York, United States
• The Mount Sinai Medical Center — New York, New York, United States
• American Health Research — Charlotte, North Carolina, United States
• Duke Asthma, Allergy and Airway Center — Durham, North Carolina, United States
• Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States
• Optimed Research, LTD — Columbus, Ohio, United States
• Toledo Institute of Clinical Research — Toledo, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Austin Regional Clinic — Austin, Texas, United States

Full record on ClinicalTrials.gov

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