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

Primary Purpose

Warm Antibody Autoimmune Hemolytic Anemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fostamatinib disodium
Placebo
Sponsored by
Rigel Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warm Antibody Autoimmune Hemolytic Anemia focused on measuring wAIHA, Warm Antibody Autoimmune Hemolytic Anemia, Warm Autoimmune Hemolytic Anemia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject must have a diagnosis of primary or secondary wAIHA as documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA.
  2. Have failed or not tolerated at least one prior wAIHA treatment regimen, including steroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, MMF, danazol, vincristine, ESA or splenectomy (folate, iron or other supplements do not fulfill this criterion).
  3. Have haptoglobin <LLN or total bilirubin >ULN or lactate dehydrogenase (LDH) >ULN.
  4. At screening, subject's hemoglobin level must be ≤9 g/dL OR if hemoglobin value >9 g/dL and <10 g/dL, subject must be on an allowed wAIHA treatment AND the subject must have documented symptoms related to anemia (e.g., weakness, dizziness, fatigue, shortness of breath, chest pain).
  5. Male or female at least 18 years of age at screening.
  6. Karnofsky performance status (KPS) ≥70.
  7. Subject's concurrent treatment for wAIHA may consist of no more than two of any of the following agents: azathioprine, steroids, ESAs, mycophenolate mofetil, dapsone or danazol at a stable dose

Exclusion Criteria:

  1. Subject with other types of AIHA (e.g., cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria).
  2. Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosus (SLE), or lymphoid malignancy if the underlying disease is not stable or is not well-controlled on current therapy, per investigator medical judgement.
  3. Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥135 mmHg or diastolic blood pressure ≥85 mmHg, whether or not the subject is receiving anti-hypertensive treatment.
  4. Subject has one or more of the following laboratory abnormalities at screening: neutrophil count of <1,000/μL or platelet count of <30,000/μL, unless due to Evans syndrome; transaminase levels (i.e., alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) >1.5 x ULN.
  5. Has documented active hepatitis B or hepatitis C infection or HIV infection.

Sites / Locations

  • Banner MD Anderson Cancer Center
  • Mayo Clinic Hospital
  • Arizona Oncology Associates, PC--HOPE Division
  • Moores UC San Diego Cancer Center
  • University of Southern California
  • Harbor UCLA - Lundquist Institute
  • The Oncology Institute of Hope and Innovation
  • Banner MD Anderson Cancer Center at North Colorado Medical Center
  • Georgetown University - Lombardi Comprehensive Cancer Center
  • Cancer Specialists of North Florida
  • Piedmont Cancer Institute
  • Affiliated Oncologists
  • John Hopkins Bayview Medical Center
  • Massachusetts General Hospital
  • Comprehensive Cancer Centers of Nevada
  • Rutgers - Robert Wood Johnson Medical School
  • Montefiore Medical Center
  • Duke Cancer Network
  • Medical University of South Carolina
  • Texas Oncology - Baylor Research Institute
  • Clear Lake Specialties, Research Dept.
  • American Oncology Network Vista Oncology Division
  • Swedish Cancer Institute
  • University of Washington
  • Versiti Wisconsin, Inc.
  • Marshfield Clinic Cancer Center - Stevens Point
  • Concord Repatriation General Hospital
  • Princess Alexandra Hospital - Cancer Trials Unit
  • The Alfred Hospital
  • Royal Perth Hospital
  • Universitätsklinik Innsbruck - Innere Medizin V
  • Universitätsklinikum Salzburg, 3.Medizin/Onkologie
  • Hanusch-Krankenhaus
  • Medizinsche Universität Wien
  • Vitebsk Regional Clinical Hospital
  • Vitebsk Regional Clinical Oncology Dispensary
  • Ziekenhuis Network Antwerp, Stuivenberg
  • Universitair Ziekenhuis Antwerpen - Hematologie
  • AZ Nikolaas
  • University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD, Pleven, Clinic of Clinical Haematology
  • University Multiprofile Hospital for Active Treatment 'Alexandrovska' EAD, Clinic of Clinical Haematology
  • University Multiprofile Hospital for Active Treatment 'Sv. Ivan Rilski' EAD, Clinic of Clinical Hematology, Department of Clinical Hematology
  • Specialized Hospital for Active Treatment of Hematological Diseases EAD, Sofia, Clinic of Clinical Haematology
  • University Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD, Varna, Clinic of Clinical Haematology
  • Hamilton Health Sciences- McMaster University Medical Centre
  • The Ottawa Hospital
  • St. Michael's Hospital
  • Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika
  • Fakultni nemocnice Ostrava Klinika hematoonkologie
  • Ustav Hematologie a Krevni Transfuze
  • Aalborg University Hopital
  • Aarhus University Hospital - Dept of Hematology
  • Herlev and Gentofte Hospital
  • CHU Angers
  • Institut d'hématologie de Basse Normandie, CHU Caen
  • CHU Estaing - Chirurgie digestive et Médecine interne
  • CHU Henri Mondor
  • Hôpital Saint Antoine
  • CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses
  • CHU Toulouse, IUCT Oncopôle
  • M. Zodelava Hematology Centre, Tbilisi
  • LTD Multiprofile Clinic Consilium Medulla
  • Universitätsklinikum Essen
  • University of Leipzig Medical Center, Medical Department I - Haematology and Cell Therapy, Medical Oncology, Hemophilia
  • Semmelweis Egyetem, Általános Orvostudományi Kar, I.sz. Belgyógyászati Klinika, Haematológiai Osztály,
  • Szabolcs-Szatmár- Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
  • Pécsi Tudományegyetem, Klinikai Központ, I.számú Belgyógyászati Klinikai, Hematológiai Tanszék
  • ASST degli Spedali Civili di Brescia, Ematologia UOC
  • Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia
  • SCDU Ematologia AOU "Maggiore della Carità"
  • Ospedale Maggiore, SC Ematologia - Azienda Sanitaria Universitaria Giuliano Isontina
  • ULSS8 Berica Ospedale San Bortolo - Unità Operativa Complessa di Ematologia
  • Academisch Medisch Centrum
  • Haukeland University Hospital
  • Østfold Hopital
  • Ålesund Hospital
  • Coltea Clinical Hospital
  • Emergency University Hospital Bucharest
  • "Prof. Dr. Ion Chiricuta" Institute of Oncology Cluj-Napoca
  • National Research Center for Hematology
  • Botkin Moscow City Clinical Hospital
  • State Budgetary Healthcare Institution of Moscow city "City Clinical Hospital No 40 Department of Healthcare of Moscow city"
  • State Budgetary Healthcare Institution of Novosibirsk Region "City Clinical Hospital №2"
  • State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
  • Regional State Autonomous Healthcare Institution "Tomsk Regional Clinical Hospital"
  • University Hospital Medical Center "Bezanijska Kosa", Department of Hematology
  • Clinical Center Nis, Clinic for Hematology
  • Clinical Centre of Vojvodina, Clinic for Hematology
  • Hospital Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Hospital Universitario Gregorio Marañón
  • Hospital Universitario Puerta de Hierro de Majadahonda
  • Hospital Universitario Virgen del Rocio
  • Hospital Universitario y Politecnico La Fe - Servicio de Hematología
  • Cherkasy Regional Oncology Dispensary, Hematology Center
  • City Clinical Hospital № 4, Hematology Center
  • Kyiv City Clinical Hospital №9, hematology department №1
  • East Kent Haemophilia Centre, Kent and Canterbury Hospital
  • Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
  • Hammersmith Hospital
  • The Royal London Hospital, Bart's Health NHS Trust
  • Sandwell and West Birmingham NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fostamatinib

Placebo

Arm Description

Initial dose is 100 mg by mouth (PO) twice a day (bid). At week 4 dose will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug in the opinion of the Investigator.

Initial dose is 100 mg by mouth (PO) twice a day (bid). At week 4 dose will be increased to placebo 150 mg PO bid if subjects have adequately tolerated the study drug in the opinion of the Investigator.

Outcomes

Primary Outcome Measures

Durable Hemoglobin Response
Proportion of subjects achieving a hemoglobin level ≥ 10 g/dL with an increase from Baseline in hemoglobin level of ≥ 2 g/dL on 3 consecutive available visits during the 24-week treatment period.

Secondary Outcome Measures

A Hemoglobin Response by Week 24
Proportion of subjects with a hemoglobin response by Week 24.
Change From Baseline in Hemoglobin Level of 2 g/dL or Greater
Proportion of subjects with change from baseline in hemoglobin level of 2 g/dL or greater.
Change in Hemoglobin From Baseline to End of Treatment
Change in mean hemoglobin from baseline to end of treatment.
Use of Rescue Antibody Autoimmune Hemolytic Anemia (AIHA) Regimens Use After Week 4
Proportion of subjects free of rescue AIHA regimens used after Week 4.
Change in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)
Change from Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-F). The FACIT-F scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. Each item is rated using a 5-point Likert-type scale. The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue. Total Score = [Sum of item scores] x [N of items in subscale] ÷ [N of items answered].

Full Information

First Posted
December 3, 2018
Last Updated
May 23, 2023
Sponsor
Rigel Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03764618
Brief Title
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA
Official Title
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
April 11, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rigel Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warm Antibody Autoimmune Hemolytic Anemia
Keywords
wAIHA, Warm Antibody Autoimmune Hemolytic Anemia, Warm Autoimmune Hemolytic Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fostamatinib
Arm Type
Experimental
Arm Description
Initial dose is 100 mg by mouth (PO) twice a day (bid). At week 4 dose will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug in the opinion of the Investigator.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Initial dose is 100 mg by mouth (PO) twice a day (bid). At week 4 dose will be increased to placebo 150 mg PO bid if subjects have adequately tolerated the study drug in the opinion of the Investigator.
Intervention Type
Drug
Intervention Name(s)
Fostamatinib disodium
Other Intervention Name(s)
R935788, Fostamatinib
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Durable Hemoglobin Response
Description
Proportion of subjects achieving a hemoglobin level ≥ 10 g/dL with an increase from Baseline in hemoglobin level of ≥ 2 g/dL on 3 consecutive available visits during the 24-week treatment period.
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
A Hemoglobin Response by Week 24
Description
Proportion of subjects with a hemoglobin response by Week 24.
Time Frame
24 weeks
Title
Change From Baseline in Hemoglobin Level of 2 g/dL or Greater
Description
Proportion of subjects with change from baseline in hemoglobin level of 2 g/dL or greater.
Time Frame
24 weeks
Title
Change in Hemoglobin From Baseline to End of Treatment
Description
Change in mean hemoglobin from baseline to end of treatment.
Time Frame
24 weeks
Title
Use of Rescue Antibody Autoimmune Hemolytic Anemia (AIHA) Regimens Use After Week 4
Description
Proportion of subjects free of rescue AIHA regimens used after Week 4.
Time Frame
24 weeks
Title
Change in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)
Description
Change from Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-F). The FACIT-F scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. Each item is rated using a 5-point Likert-type scale. The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue. Total Score = [Sum of item scores] x [N of items in subscale] ÷ [N of items answered].
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must have a diagnosis of primary or secondary warm Antibody Autoimmune Hemolytic Anemia (wAIHA) as documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA. Have failed or not tolerated at least one prior wAIHA treatment regimen, including steroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, MMF, danazol, vincristine, ESA or splenectomy (folate, iron or other supplements do not fulfill this criterion). Have haptoglobin <LLN or total bilirubin >ULN or lactate dehydrogenase (LDH) >ULN. At screening, subject's hemoglobin level must be ≤9 g/dL OR if hemoglobin value >9 g/dL and <10 g/dL, subject must be on an allowed wAIHA treatment AND the subject must have documented symptoms related to anemia (e.g., weakness, dizziness, fatigue, shortness of breath, chest pain). Karnofsky performance status (KPS) ≥70. Subject's concurrent treatment for wAIHA may consist of no more than two of any of the following agents: azathioprine, steroids, ESAs, mycophenolate mofetil, dapsone or danazol at a stable dose Exclusion Criteria: Subject with other types of Antibody Autoimmune Hemolytic Anemia (AIHA) (e.g., cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria). Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosus (SLE), or lymphoid malignancy if the underlying disease is not stable or is not well-controlled on current therapy, per investigator medical judgement. Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥135 mmHg or diastolic blood pressure ≥85 mmHg, whether or not the subject is receiving anti-hypertensive treatment. Subject has one or more of the following laboratory abnormalities at screening: neutrophil count of <1,000/μL or platelet count of <30,000/μL, unless due to Evans syndrome; transaminase levels (i.e., alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) >1.5 x ULN. Has documented active hepatitis B or hepatitis C infection or HIV infection.
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Arizona Oncology Associates, PC--HOPE Division
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Moores UC San Diego Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Harbor UCLA - Lundquist Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Banner MD Anderson Cancer Center at North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Georgetown University - Lombardi Comprehensive Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Piedmont Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Affiliated Oncologists
City
Chicago Ridge
State/Province
Illinois
ZIP/Postal Code
60415
Country
United States
Facility Name
John Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Rutgers - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Duke Cancer Network
City
Clayton
State/Province
North Carolina
ZIP/Postal Code
27520
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Oncology - Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Clear Lake Specialties, Research Dept.
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
American Oncology Network Vista Oncology Division
City
Olympia
State/Province
Washington
ZIP/Postal Code
98506
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Versiti Wisconsin, Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Marshfield Clinic Cancer Center - Stevens Point
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54482
Country
United States
Facility Name
Concord Repatriation General Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Princess Alexandra Hospital - Cancer Trials Unit
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4201
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Universitätsklinik Innsbruck - Innere Medizin V
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Universitätsklinikum Salzburg, 3.Medizin/Onkologie
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Hanusch-Krankenhaus
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Medizinsche Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Vitebsk Regional Clinical Hospital
City
Vitebsk
ZIP/Postal Code
210037
Country
Belarus
Facility Name
Vitebsk Regional Clinical Oncology Dispensary
City
Vitebsk
ZIP/Postal Code
210603
Country
Belarus
Facility Name
Ziekenhuis Network Antwerp, Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen - Hematologie
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
AZ Nikolaas
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD, Pleven, Clinic of Clinical Haematology
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment 'Alexandrovska' EAD, Clinic of Clinical Haematology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment 'Sv. Ivan Rilski' EAD, Clinic of Clinical Hematology, Department of Clinical Hematology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Hematological Diseases EAD, Sofia, Clinic of Clinical Haematology
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD, Varna, Clinic of Clinical Haematology
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Hamilton Health Sciences- McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava Klinika hematoonkologie
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Ustav Hematologie a Krevni Transfuze
City
Praha
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Aalborg University Hopital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus University Hospital - Dept of Hematology
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Herlev and Gentofte Hospital
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Institut d'hématologie de Basse Normandie, CHU Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Estaing - Chirurgie digestive et Médecine interne
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHU Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses
City
Pessac
ZIP/Postal Code
33603
Country
France
Facility Name
CHU Toulouse, IUCT Oncopôle
City
Toulouse
ZIP/Postal Code
31100
Country
France
Facility Name
M. Zodelava Hematology Centre, Tbilisi
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
LTD Multiprofile Clinic Consilium Medulla
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
University of Leipzig Medical Center, Medical Department I - Haematology and Cell Therapy, Medical Oncology, Hemophilia
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Semmelweis Egyetem, Általános Orvostudományi Kar, I.sz. Belgyógyászati Klinika, Haematológiai Osztály,
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Szabolcs-Szatmár- Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pécsi Tudományegyetem, Klinikai Központ, I.számú Belgyógyászati Klinikai, Hematológiai Tanszék
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
ASST degli Spedali Civili di Brescia, Ematologia UOC
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
SCDU Ematologia AOU "Maggiore della Carità"
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Ospedale Maggiore, SC Ematologia - Azienda Sanitaria Universitaria Giuliano Isontina
City
Trieste
ZIP/Postal Code
34125
Country
Italy
Facility Name
ULSS8 Berica Ospedale San Bortolo - Unità Operativa Complessa di Ematologia
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Academisch Medisch Centrum
City
Amsterdam
Country
Netherlands
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Østfold Hopital
City
Grålum
ZIP/Postal Code
1714
Country
Norway
Facility Name
Ålesund Hospital
City
Ålesund
ZIP/Postal Code
6017
Country
Norway
Facility Name
Coltea Clinical Hospital
City
Bucharest
ZIP/Postal Code
030171
Country
Romania
Facility Name
Emergency University Hospital Bucharest
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
"Prof. Dr. Ion Chiricuta" Institute of Oncology Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
National Research Center for Hematology
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Botkin Moscow City Clinical Hospital
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Moscow city "City Clinical Hospital No 40 Department of Healthcare of Moscow city"
City
Moscow
ZIP/Postal Code
129301
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Novosibirsk Region "City Clinical Hospital №2"
City
Novosibirsk
ZIP/Postal Code
630051
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Regional State Autonomous Healthcare Institution "Tomsk Regional Clinical Hospital"
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
University Hospital Medical Center "Bezanijska Kosa", Department of Hematology
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Nis, Clinic for Hematology
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Clinical Centre of Vojvodina, Clinic for Hematology
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro de Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe - Servicio de Hematología
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Cherkasy Regional Oncology Dispensary, Hematology Center
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
City Clinical Hospital № 4, Hematology Center
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital №9, hematology department №1
City
Kyiv
ZIP/Postal Code
04112
Country
Ukraine
Facility Name
East Kent Haemophilia Centre, Kent and Canterbury Hospital
City
Canterbury
State/Province
Kent
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
Country
United Kingdom
Facility Name
The Royal London Hospital, Bart's Health NHS Trust
City
London
Country
United Kingdom
Facility Name
Sandwell and West Birmingham NHS Trust
City
West Bromwich
ZIP/Postal Code
B71 4HJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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