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

PHASE3CompletedINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

March 3, 2016

Primary Completion Date

April 13, 2017

Study Completion Date

April 13, 2017

Conditions
Hereditary Angioedema (HAE)
Interventions
DRUG

DX-2930 - 300mg/2wk

300 mg DX-2930 administered every 2 weeks by subcutaneous injection.

DRUG

DX-2930 - 300mg/4wk

300 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.

DRUG

DX-2930 - 150mg/4wk

150 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.

DRUG

Placebo

Placebo administered every 2 weeks by subcutaneous injection.

Trial Locations (41)

10029

The Mount Sinai Medical Center, New York

10117

Charité - University of Berlin, Berlin

11501

Winthrop University Hospital, Mineola

11941

Triumpharma, Amman

17033

Penn State Milton S. Hershey Medical Center, Hershey

20157

Hospital L. Sacco, Milan University, Milan

20815

Institute of Asthma & Allergy, P.C., Chevy Chase

23219

Virginia Commonwealth University, Richmond

27705

Duke Asthma, Allergy and Airway Center, Durham

28277

American Health Research, Charlotte

33613

University of South Florida, Tampa

35209

Clinical Research Center of Alabama, LLC, Birmingham

43235

Optimed Research, LTD, Columbus

43617

Toledo Institute of Clinical Research, Toledo

45231

Bernstein Clinical Research Center, LLC, Cincinnati

48106

University of Michigan Hospital and Health System, Ann Arbor

53226

Children's Hospital of Wisconsin, Milwaukee

55131

Hautklinik und Poliklinik der Universitätsmedizin, Mainz

55446

Midwest Immunology Clinic, Plymouth

63110

Washington University School of Medicine, St Louis

64546

HZRM Hamophilie-Zentrum Rhein Main, Mörfelden-Walldorf

66160

University of Kansas Medical Center, Kansas City

75231

AARA Research Center, Dallas

78731

Austin Regional Clinic, Austin

80112

IMMUNOe International Health & Research Centers, Centennial

80907

Asthma and Allergy Associates, P.C., Colorado Springs

84020

Intermountain Clinical Research, Draper

84107

Allergy Associates of Utah, Murray

85251

Medical Research of Arizona, Scottsdale

90404

AIRE Medical of Los Angeles, Santa Monica

92122

UC San Diego School of Medicine, San Diego

94598

Allergy & Asthma Clinical Research, Walnut Creek

99202

Marycliff Allergy Specialists, Spokane

02421

Massachusetts General Hospital, Boston

07109

Hudson-Essex Allergy, LLC, Belleville

07712

Atlantic Research Center, LLC, Ocean City

K1G 6C6

Ottawa Allergy Research Corporation, Ottawa

M4V 1R2

Gordon Sussman Clinical Research Inc., Toronto

G1V 4M6

Clinique Specialisee en Allergie de la Capitale, Québec

00918

Sociedad Alergologica, San Juan

E1 2ES

Barts Health NHS Trust Clinical Research Centre, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Dyax Corp.

INDUSTRY

lead

Shire

INDUSTRY

NCT02586805 - Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE | Biotech Hunter | Biotech Hunter