A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
NCT ID: NCT04138927
Last Updated: 2022-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE3
90 participants
INTERVENTIONAL
2019-10-30
2024-04-30
Brief Summary
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• To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fostamatinib
Subjects who at any time during the C-935788-057 study achieved a hemoglobin response will continue at their dose and regimen from the Week 22 visit in the C-935788-057 study.
All other subjects who enter the extension study will initially receive fostamatinib 100 mg PO bid. Starting at Week 4, the initial fostamatinib dose of 100 mg PO bid will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug, based on the Investigator's judgment.
Fostamatinib disodium
Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.
Interventions
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Fostamatinib disodium
Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject must have completed all 24 weeks of participation in the study C-935788-057.
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Rigel Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory
Los Angeles, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
John Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
American Oncology Network Vista Oncology Division
Olympia, Washington, United States
University of Washington
Seattle, Washington, United States
Princess Alexandra Hospital - Cancer Trials Unit
Brisbane, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Hanusch-Krankenhaus
Vienna, , Austria
Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie
Vienna, , Austria
Vitebsk Regional Clinical Hospital
Vitebsk, , Belarus
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, , Belarus
AZ Nikolaas
Sint-Niklaas, , Belgium
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic of Medical oncology
Pleven, , Bulgaria
University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology
Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Hematological Disease EAD,
Sofia, , Bulgaria
Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika
Brno, , Czechia
Fakultni nemocnice Ostrava Klinika hematoonkologie
Ostrava, , Czechia
CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses
Pessac, , France
LTD Multiprofile Clinic Consilium Medulla
Tbilisi, , Georgia
M. Zodelava Hematology Centre, Tbilisi
Tbilisi, , Georgia
Universitätsklinikum Essen
Essen, , Germany
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia
Milan, , Italy
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia
Milan, , Italy
SCDU Ematologia AOU "Maggiore della Carità"
Novara, , Italy
Academisch Medisch Centrum
Amsterdam, , Netherlands
Haukeland University Hospital
Bergen, , Norway
National Research Center for Hematology
Moscow, , Russia
State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
Sochi, , Russia
Clinical Centre of Vojvodina, Clinic for Hematology
Novi Sad, , Serbia
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
City Clinical Hospital № 4, Hematology Center
Dnipro, , Ukraine
Kyiv City Clinical Hospital №9, hematology department №1
Kyiv, , Ukraine
Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
Liverpool, , United Kingdom
Countries
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Other Identifiers
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C-935788-058
Identifier Type: -
Identifier Source: org_study_id
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