A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA

PHASE3CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

April 24, 2019

Primary Completion Date

April 11, 2022

Study Completion Date

April 11, 2022

Conditions
Warm Antibody Autoimmune Hemolytic Anemia
Interventions
DRUG

Fostamatinib disodium

"Fostamatinib (100mg PO bid or 150 mg PO bid)~The dose may be reduced at any time to a dose as low as fostamatinib 100 mg PO qd or matching placebo if dose limiting adverse events are observed."

DRUG

Placebo

Placebo

Trial Locations (102)

1083

Semmelweis Egyetem, Általános Orvostudományi Kar, I.sz. Belgyógyászati Klinika, Haematológiai Osztály,, Budapest

1090

Medizinsche Universität Wien, Vienna

1140

Hanusch-Krankenhaus, Vienna

1431

University Multiprofile Hospital for Active Treatment 'Alexandrovska' EAD, Clinic of Clinical Haematology, Sofia

University Multiprofile Hospital for Active Treatment 'Sv. Ivan Rilski' EAD, Clinic of Clinical Hematology, Department of Clinical Hematology, Sofia

1714

Østfold Hopital, Grålum

1756

Specialized Hospital for Active Treatment of Hematological Diseases EAD, Sofia, Clinic of Clinical Haematology, Sofia

2060

Ziekenhuis Network Antwerp, Stuivenberg, Antwerp

2139

Concord Repatriation General Hospital, Sydney

2650

Universitair Ziekenhuis Antwerpen - Hematologie, Edegem

3004

The Alfred Hospital, Melbourne

4201

Princess Alexandra Hospital - Cancer Trials Unit, Brisbane

4400

Szabolcs-Szatmár- Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház, Nyíregyháza

5020

Universitätsklinikum Salzburg, 3.Medizin/Onkologie, Salzburg

5021

Haukeland University Hospital, Bergen

5800

University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD, Pleven, Clinic of Clinical Haematology, Pleven

6000

Royal Perth Hospital, Perth

6017

Ålesund Hospital, Ålesund

6020

Universitätsklinik Innsbruck - Innere Medizin V, Innsbruck

7624

Pécsi Tudományegyetem, Klinikai Központ, I.számú Belgyógyászati Klinikai, Hematológiai Tanszék, Pécs

8200

Aarhus University Hospital - Dept of Hematology, Aarhus N

9000

Aalborg University Hopital, Aalborg

9010

University Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD, Varna, Clinic of Clinical Haematology, Varna

9100

AZ Nikolaas, Sint-Niklaas

10461

Montefiore Medical Center, The Bronx

11080

"University Hospital Medical Center Bezanijska Kosa, Department of Hematology", Belgrade

14033

Institut d'hématologie de Basse Normandie, CHU Caen, Caen

18000

Clinical Center Nis, Clinic for Hematology, Niš

18009

Cherkasy Regional Oncology Dispensary, Hematology Center, Cherkasy

20007

Georgetown University - Lombardi Comprehensive Cancer Center, Washington D.C.

20122

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia, Milan

21000

Clinical Centre of Vojvodina, Clinic for Hematology, Novi Sad

21205

John Hopkins Bayview Medical Center, Baltimore

25123

ASST degli Spedali Civili di Brescia, Ematologia UOC, Brescia

27520

Duke Cancer Network, Clayton

28009

Hospital Universitario Gregorio Marañón, Madrid

28100

"SCDU Ematologia AOU Maggiore della Carità", Novara

28222

Hospital Universitario Puerta de Hierro de Majadahonda, Madrid

29425

Medical University of South Carolina, Charleston

30318

Piedmont Cancer Institute, Atlanta

31100

CHU Toulouse, IUCT Oncopôle, Toulouse

32256

Cancer Specialists of North Florida, Jacksonville

33603

CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses, Pessac

34125

Ospedale Maggiore, SC Ematologia - Azienda Sanitaria Universitaria Giuliano Isontina, Trieste

36100

ULSS8 Berica Ospedale San Bortolo - Unità Operativa Complessa di Ematologia, Vicenza

41013

Hospital Universitario Virgen del Rocio, Seville

45147

Universitätsklinikum Essen, Essen

46026

Hospital Universitario y Politecnico La Fe - Servicio de Hematología, Valencia

49100

CHU Angers, Angers

49102

City Clinical Hospital № 4, Hematology Center, Dnipro

53226

Versiti Wisconsin, Inc., Milwaukee

54482

Marshfield Clinic Cancer Center - Stevens Point, Stevens Point

60415

Affiliated Oncologists, Chicago Ridge

63003

CHU Estaing - Chirurgie digestive et Médecine interne, Clermont-Ferrand

70852

Fakultni nemocnice Ostrava Klinika hematoonkologie, Ostrava

75012

Hôpital Saint Antoine, Paris

75246

Texas Oncology - Baylor Research Institute, Dallas

77598

Clear Lake Specialties, Research Dept., Webster

80538

Banner MD Anderson Cancer Center at North Colorado Medical Center, Greeley

85054

Mayo Clinic Hospital, Phoenix

85234

Banner MD Anderson Cancer Center, Gilbert

85711

Arizona Oncology Associates, PC--HOPE Division, Tucson

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90033

University of Southern California, Los Angeles

90502

Harbor UCLA - Lundquist Institute, Torrance

90603

The Oncology Institute of Hope and Innovation, Whittier

92037

Moores UC San Diego Cancer Center, La Jolla

94000

CHU Henri Mondor, Créteil

98104

Swedish Cancer Institute, Seattle

98109

University of Washington, Seattle

98506

American Oncology Network Vista Oncology Division, Olympia

125167

National Research Center for Hematology, Moscow

125284

Botkin Moscow City Clinical Hospital, Moscow

129301

"State Budgetary Healthcare Institution of Moscow city City Clinical Hospital No 40 Department of Healthcare of Moscow city", Moscow

210037

Vitebsk Regional Clinical Hospital, Vitebsk

210603

Vitebsk Regional Clinical Oncology Dispensary, Vitebsk

354057

State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory, Sochi

400015

"Prof. Dr. Ion Chiricuta Institute of Oncology Cluj-Napoca", Cluj-Napoca

630051

"State Budgetary Healthcare Institution of Novosibirsk Region City Clinical Hospital №2", Novosibirsk

634063

"Regional State Autonomous Healthcare Institution Tomsk Regional Clinical Hospital", Tomsk

02114

Massachusetts General Hospital, Boston

08901

Rutgers - Robert Wood Johnson Medical School, New Brunswick

L8S 4K1

Hamilton Health Sciences- McMaster University Medical Centre, Hamilton

K1H8L6

The Ottawa Hospital, Ottawa

M5B 1W8

St. Michael's Hospital, Toronto

625 00

Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika, Brno

128 00

Ustav Hematologie a Krevni Transfuze, Prague

DK-2730

Herlev and Gentofte Hospital, Herlev

0112

M. Zodelava Hematology Centre, Tbilisi, Tbilisi

0186

LTD Multiprofile Clinic Consilium Medulla, Tbilisi

04103

University of Leipzig Medical Center, Medical Department I - Haematology and Cell Therapy, Medical Oncology, Hemophilia, Leipzig

Unknown

Academisch Medisch Centrum, Amsterdam

Hammersmith Hospital, London

The Royal London Hospital, Bart's Health NHS Trust, London

030171

Coltea Clinical Hospital, Bucharest

050098

Emergency University Hospital Bucharest, Bucharest

08035

Hospital Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

04112

Kyiv City Clinical Hospital №9, hematology department №1, Kyiv

CT1 3NG

East Kent Haemophilia Centre, Kent and Canterbury Hospital, Canterbury

L7 8XP

Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust, Liverpool

B71 4HJ

Sandwell and West Birmingham NHS Trust, West Bromwich

Sponsors
All Listed Sponsors
lead

Rigel Pharmaceuticals

INDUSTRY