A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)

PHASE3CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 5, 2018

Primary Completion Date

October 5, 2021

Study Completion Date

October 5, 2021

Conditions
Agglutinin Disease, Cold
Interventions
DRUG

BIVV009

Sutimlimab was administered as intravenous (IV) infusion.

Trial Locations (49)

1090

Medical University of Vienna, Vienna

1105

Academisch Medisch Centrum, Amsterdam

1307

Gemeinschaftspraxis Hämatologie-Onkologie, Dresden

2060

ZNA Stuivenberg, Antwerp

3000

University Hospitals Leuven, Leuven

3168

Monash Medical Centre, Clayton

3350

Ballarat Oncology & Haematology, Ballarat

4556

USC Health Clinics, Buderim

5053

Haukeland University Hospital, Bergen

7030

St Olavs Hospital, Avdeling for blodsykdommer, Trondheim

7100

Centre Hospitalier Jolimont, La Louvière

10461

Montefiore Medical Center, New York

10595

New York Medical College at Westchester Medical Center, Valhalla

14033

CHU de Caen, Caen

15232

University of Pittsburgh Medical Center, Pittsburgh

19104

Hospital of the University of Pennsylvania, Philadelphia

20007

Georgetown University Medical Center, Georgetown

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

25123

A. O. Spedali Civili di Brescia, Brescia

27834

East Carolina University, Greenville

28222

Hospital Universitario Puerta de Hierro, Majadahonda

36100

U.O.C. Ematologia Ospedale San Bortolo, Vicenza

41013

Hospital Universitario Virgen del Rocio, Seville

44195

Cleveland Clinic, Cleveland

45147

Universitätsklinikum Essen, Essen

46017

Hospital Universitario Dr. Peset, Valencia

53792

UW Hospitals and Clinics, Madison

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

69495

Centre Hospitalier Lyon Sud, Lyon

85711

Arizona Oncology Associates PC, Tucson

89081

Univ Ulm, Inst Klin. Transfusions. Immungen, Ulm

90033

USC/Keck School of Medicine, Los Angeles

90603

The Oncology Institute of Hope and Innovation, Whittier

91120

Hadassah Medical Center, Jerusalem

94000

Centre Hospitalier Henri Mondor, Créteil

4244916

Laniado Hospital, Netanya

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

M5B1W8

St. Michael's Hospital, Toronto

H4A3J1

McGill University Health Center, Montreal

T6G1Z1

University of Alberta, Edmonton

00168

"U.O.C. Ematologia- Policlinico A. Gemelli", Rome

259-1193

Tokai University Hospital, Isehara

350-0495

Saitama Medical University Hospital, Iruma-gun

177-8521

Juntendo University Nerima Hospital, Tokyo

0372

Oslo University Hospital, Oslo

08036

Hospital Clinci i Provincial de Barcelona, Barcelona

LS9 7TF

St James Hospital, Leeds, Leeds

WC1E 6AG

University College London, London

All Listed Sponsors
lead

Bioverativ, a Sanofi company

INDUSTRY

NCT03347396 - A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study) | Biotech Hunter | Biotech Hunter