Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE

PHASE3CompletedINTERVENTIONAL
Enrollment

212

Participants

Timeline

Start Date

May 26, 2016

Primary Completion Date

October 31, 2019

Study Completion Date

October 31, 2019

Conditions
Hereditary Angioedema (HAE)
Interventions
DRUG

DX-2930

Participants who rollover from the DX-2930-03 study will receive 300 milligram (mg) DX-2930 subcutaneous injection at Day 0 followed by second dose following the first HAE attack and then once in every 2 weeks until the end of the treatment period (up to 924 days). A wash-out period of a minimum of 10 days and a maximum of 18 days is required between subsequent administrations.

DRUG

DX-2930

Participants who were not participants in DX-2930-03 will receive 300 milligram (mg) DX-2930 subcutaneous injection once in every 2 weeks until the end of the treatment period (up to 924 days).

Trial Locations (43)

10029

Icahn School of Medicine at Mount Sinai, New York

10117

Charité - Universitätsmedizin Berlin, Berlin

11501

Winthrop University Hospital, Mineola

11941

Triumpharma Clinical Evaluation Centre, Amman

17033

Penn State Hershey Medical Center, Hershey

20157

University of Milan Luigi Sacco Hospital, Milan

20815

Institute Asthma and Allergy, Chevy Chase

23219

Virginia Commonwealth University, Richmond

27705

Duke Asthma, Allergy, and Airway Center, Durham

28277

Clinical Research Center of Charlotte, Charlotte

33613

University of South Florida, Tampa

35209

Clinical Research Center of Alabama, Birmingham

43235

Optimed Research, LTD., Columbus

43617

Toledo Institute of Clinical REsearch, Toledo

45231

Bernstein Clinical Research Center, LLC, Cincinnati

48106

University of Michigan, Ann Arbor

53226

Medical College of Wisconsin, Childrens Hospital, Milwaukee

55101

Hautklinik der Universitätsmedizin Mainz, Mainz

55446

Midwest Immunology Clinic, Plymouth

60596

Universitätsklinikum Frankfurt, Frankfurt

63110

Washington University School of Medicine, St Louis

64546

HZRM Hamophilie Zentrum Rhein Main GmbH, Mörfelden-Walldorf

66160

University of Kansas Medical Center, Kansas City

75231

AARA Research Center, Dallas

78731

Austin Regional Clinic, Austin

80112

IMMUNOe Research Centers, Centennial

80907

Asthma and Allergy Associates, PC, 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

University of California San Diego, San Diego

94598

Allergy & Asthma Clinical Research, Walnut Creek

99202

Premier Clinical Research, Spokane

02421

Massachusetts General Hospital, Boston

07109

Hudson-Essex Allergy, LLC, Belleville

07712

Atlantic Research Center, LLC, Ocean City

T6G 2V2

University of Alberta Hospital, Edmonton

K1G 6C6

Yang Medicine, Ottawa

M4V 1R2

Gordon Sussman Clinical Research, Inc., Toronto

G1V 4M6

Clinique Spécialisée en Allergie de la Capitale, Québec

00918

Adler Medical Plaza, San Juan

E1 1BB

Royal London Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY