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The primary objective of this study is:
• To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fostamatinib | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostamatinib disodium | Drug | Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study | 104 weeks |
| Blood Pressure | Change from baseline in blood pressure over time | 104 weeks |
| Absolute Neutrophil Count (ANC) | Change from baseline in absolute neutrophil count (ANC) over time | 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of Durable Hemoglobin Response | 24 weeks | |
| Total Duration of Response | During the Intervention period up to 104 weeks | |
| Corticosteroid dose |
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Inclusion Criteria:
Exclusion Criteria:
1. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory | Los Angeles | California | 90033 | United States |
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Net cumulative change from Baseline in corticosteroid dose |
| During the Intervention period up to 104 weeks |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
| John Hopkins Bayview Medical Center | Baltimore | Maryland | 21205 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| American Oncology Network Vista Oncology Division | Olympia | Washington | 98506 | United States |
| University of Washington | Seattle | Washington | 98109 | United States |
| Princess Alexandra Hospital - Cancer Trials Unit | Brisbane | Queensland | 4201 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Hanusch-Krankenhaus | Vienna | 1140 | Austria |
| Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie | Vienna | A-1090 | Austria |
| Vitebsk Regional Clinical Hospital | Vitebsk | 210037 | Belarus |
| Vitebsk Regional Clinical Oncology Dispensary | Vitebsk | 210603 | Belarus |
| AZ Nikolaas | Sint-Niklaas | 9100 | Belgium |
| University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic of Medical oncology | Pleven | 5800 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology | Sofia | 1431 | Bulgaria |
| Specialized Hospital for Active Treatment of Hematological Disease EAD, | Sofia | 1756 | Bulgaria |
| Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika | Brno | 625 00 | Czechia |
| Fakultni nemocnice Ostrava Klinika hematoonkologie | Ostrava | 70852 | Czechia |
| CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses | Pessac | 33603 | France |
| LTD Multiprofile Clinic Consilium Medulla | Tbilisi | 0186 | Georgia |
| M. Zodelava Hematology Centre, Tbilisi | Tbilisi | 0186 | Georgia |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia | Milan | Italy |
| Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia | Milan | 20122 | Italy |
| SCDU Ematologia AOU "Maggiore della Carità" | Novara | 28100 | Italy |
| Academisch Medisch Centrum | Amsterdam | Netherlands |
| Haukeland University Hospital | Bergen | 5021 | Norway |
| National Research Center for Hematology | Moscow | 125167 | Russia |
| State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory | Sochi | 354057 | Russia |
| Clinical Centre of Vojvodina, Clinic for Hematology | Novi Sad | 21000 | Serbia |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| City Clinical Hospital № 4, Hematology Center | Dnipro | 49102 | Ukraine |
| Kyiv City Clinical Hospital №9, hematology department №1 | Kyiv | 04112 | Ukraine |
| Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust | Liverpool | L7 8XP | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 7, 2023 | Dec 26, 2023 | 11 |
| ID | Term |
|---|---|
| C523665 | fostamatinib |
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