Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

April 29, 2021

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Hereditary Angioedema
Interventions
BIOLOGICAL

CSL312

Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody

Trial Locations (44)

407

Taichung Veterans General Hospital, Taichung

1023

Auckland City Hospital, Grafton

1088

Semmelweis Egyetem Altalanos Orvostudományi Kar Belgyógyászati és Hematológiai Klinika, Budapest

1105

Amsterdam UMC, location AMC, Amsterdam

2560

Campbelltown Hospital / Western Sydney University, Campbelltown

3004

The Alfred Hospital, Melbourne

6150

Fiona Stanley Hospital, Department of Clinical Immunology, Murdoch

8035

Hospital Universitari General de La Vall d'Hebron, Barcelona

10117

Charité - Universitätsmedizin Berlin, Berlin

17033

PennState Health Milton S. Hershey Medical Center, Hershey

20815

Institute for Asthma and Allergy PC, Chevy Chase

28007

Hospital Gregorio Marañón, Servicio de Alergia, Madrid

35209

Clinical Research Center of Alabama, Birmingham

45236

Bernstein Clinical Research Center, LLC, Cincinnati

55131

Johannes Gutenberg-Universität KöR, Hautklinik und Poliklinik der Universitätsmedizin, Clinical Research Center, Mainz

60590

Universitätsklinikum Frankfurt, Frankfurt

64546

HZRM Haemophilie Zentrum Rhein Main GmbH, Mörfelden-Walldorf

65691

University hospital St. Anna Ustav klinicke imunologie a alergologie, Fakultní nemocnice u sv. Anny v Brně, Brno

72205

Little Rock Allergy & Asthma Clinic, Little Rock

75231

AARA Research Center, Dallas

85251

Medical Research of Arizona, Scottsdale

85340

Research Solutions of Arizona, Litchfield Park

90404

Raffi Tachdjian MD, Inc., Santa Monica

92868

Donald S. Levy M.D., Orange

94598

Allergy & Asthma Clinical Research, Walnut Creek

115522

NRC Institute of Immunology FMBA Russia, Moscow

7830604

Barzilai University Medical Center, Ashkelon

T6G 2B7

University of Alberta - Research Transition Facility, Edmonton

L8N 3Z5

McMaster University, Hamilton

K1H 1E4

Ottawa Allergy Research Corp, Ottawa

M3B 3S6

Gordon Sussman Clinical Research, Toronto

H2W 1R7

Montreal Clinical Research Institute, Montreal

150 06

University Hospital Motol, Prague

Unknown

The University of Hong Kong, Queen Mary Hospital, Hong Kong

425-0088

Koga Community Hospital, Shizuoka

Edobashi, Tsu-shi

Mie University Hospital, Mie

113-8431

Juntendo University Hospital, Tokyo

350-8550

Saitama Medical Center, Saitama

216-8511

St. Marianna University School of Medicine Hospital, Kanagawa

251-0025

Clover Hospital, Kanagawa

340-0041

Saiyu Soka Hospital, Saitama

190-0014

National Hospital Organization Disaster Medical Center, Tokyo

849-8501

Saga University Hospital, Saga

534-0021

Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital, Miyakojima-ku

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY