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

Use our guide to learn which trials are right for you!

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
sites
Chevy Chase, Maryland 20815
Principal Investigator: Huamin Henry Li, MD, PhD
Phone: 301-986-0670
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Aleena Banerji, MD
Phone: 617-724-1714
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Austin, Texas 78731
Principal Investigator: William Otto, MD
Phone: 512-344-0362
?
mi
from
Austin, TX
Click here to add this to my saved trials
Belleville, New Jersey 07109
Principal Investigator: Mark E Weinstein, MD
Phone: 973-759-5842
?
mi
from
Belleville, NJ
Click here to add this to my saved trials
Birmingham, Alabama 35209
Principal Investigator: John Anderson, MD
Phone: 205-209-4131
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Centennial, CO
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Cincinnati, Ohio 45231
Principal Investigator: Jonathan A Bernstein, MD
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
Principal Investigator: Daniel Soteres, MD, MPH
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbus, Ohio 43235
Principal Investigator: Donald L McNeil, MD
Phone: 614-430-8022
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dallas, Texas 75231
Principal Investigator: William R Lumry, MD
Phone: 214-365-0365
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Draper, Utah 84020
Principal Investigator: Duane J Harris, MD
Phone: 801-553-2379
?
mi
from
Draper, UT
Click here to add this to my saved trials
Durham, North Carolina 27704
Principal Investigator: Patricia Lugar, MD
Phone: 919-684-2281
?
mi
from
Durham, NC
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
?
mi
from
Hershey, PA
Click here to add this to my saved trials
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...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
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,...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
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,...
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Murray, Utah 84107
?
mi
from
Murray, UT
Click here to add this to my saved trials
Ocean City, New Jersey 07712
?
mi
from
Ocean City, NJ
Click here to add this to my saved trials
?
mi
from
Ottawa,
Click here to add this to my saved trials
Plymouth, Minnesota 55446
Principal Investigator: Ralph Shapiro, MD
Phone: 763-577-0008
?
mi
from
Plymouth, MN
Click here to add this to my saved trials
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...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
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...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Diego, California 92122
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Monica, California 90404
Principal Investigator: Raffi Tachdjian, MD
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85251
Principal Investigator: Michael E Manning, MD
Phone: 480-675-8982
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Toledo, Ohio 43617
Principal Investigator: Syed Rehman, MD
Phone: 419-843-8815
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Walnut Creek, California 94598
Principal Investigator: Joshua S Jacobs, MD
Phone: 925-935-2599
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials