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



Status:Completed
Conditions:Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:4/26/2018
Start Date:March 3, 2016
End Date:April 13, 2017

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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)

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.


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.
We found this trial at
32
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Aleena Banerji, MD
Phone: 617-724-1714
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
1289
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New York, NY
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Richard F Lockey, MD
University of South Florida The University of South Florida is a high-impact, global research university...
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808
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Ann Arbor, MI
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Austin, Texas 78731
Principal Investigator: William Otto, MD
Phone: 512-344-0362
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Austin, TX
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Belleville, New Jersey 07109
Principal Investigator: Mark E Weinstein, MD
Phone: 973-759-5842
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Birmingham, Alabama 35209
Principal Investigator: John Anderson, MD
Phone: 205-209-4131
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Birmingham, AL
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399
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Centennial, CO
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Charlotte, North Carolina 28207
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Charlotte, NC
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Chevy Chase, Maryland 20815
Principal Investigator: Huamin Henry Li, MD, PhD
Phone: 301-986-0670
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Cincinnati, Ohio 45231
Principal Investigator: Jonathan A Bernstein, MD
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Colorado Springs, Colorado 80907
Principal Investigator: Daniel Soteres, MD, MPH
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Columbus, Ohio 43235
Principal Investigator: Donald L McNeil, MD
Phone: 614-430-8022
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Dallas, Texas 75231
Principal Investigator: William R Lumry, MD
Phone: 214-365-0365
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Draper, Utah 84020
Principal Investigator: Duane J Harris, MD
Phone: 801-553-2379
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Durham, North Carolina 27704
Principal Investigator: Patricia Lugar, MD
Phone: 919-684-2281
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
190
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: Heidi T Zafra, MD
Phone: 414-266-6165
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
630
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259 1st St
Mineola, New York 11501
(516) 663-0333
Principal Investigator: Mark Davis-Lorton, MD
Phone: 516-663-9709
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Murray, Utah 84107
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Ocean City, New Jersey 07712
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Ottawa,
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Plymouth, Minnesota 55446
Principal Investigator: Ralph Shapiro, MD
Phone: 763-577-0008
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Lawrence Schwartz, MD
Phone: 804-828-9685
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Diego, California 92122
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Santa Monica, California 90404
Principal Investigator: Raffi Tachdjian, MD
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Scottsdale, Arizona 85251
Principal Investigator: Michael E Manning, MD
Phone: 480-675-8982
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Spokane, Washington 99204
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Toledo, Ohio 43617
Principal Investigator: Syed Rehman, MD
Phone: 419-843-8815
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Walnut Creek, California 94598
Principal Investigator: Joshua S Jacobs, MD
Phone: 925-935-2599
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