A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Warm Antibody Autoimmune Hemolytic Anemia
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
Inclusion Criteria:
- Subject must be willing and able to give written informed consent by signing an IRB approved Informed Consent Form prior to undergoing any study-specific procedures.
- Subject must have completed all 24 weeks of participation in the study C-935788-057.
Exclusion Criteria:
1. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.
Sites / Locations
- University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Lombardi Comprehensive Cancer Center
- John Hopkins Bayview Medical Center
- Massachusetts General Hospital
- Comprehensive Cancer Centers of Nevada
- American Oncology Network Vista Oncology Division
- University of Washington
- Princess Alexandra Hospital - Cancer Trials Unit
- The Alfred Hospital
- Hanusch-Krankenhaus
- Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie
- Vitebsk Regional Clinical Hospital
- Vitebsk Regional Clinical Oncology Dispensary
- AZ Nikolaas
- University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic of Medical oncology
- University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology
- Specialized Hospital for Active Treatment of Hematological Disease EAD,
- Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika
- Fakultni nemocnice Ostrava Klinika hematoonkologie
- CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses
- LTD Multiprofile Clinic Consilium Medulla
- M. Zodelava Hematology Centre, Tbilisi
- Universitätsklinikum Essen
- Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia
- SCDU Ematologia AOU "Maggiore della Carità"
- Academisch Medisch Centrum
- Haukeland University Hospital
- National Research Center for Hematology
- State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
- Clinical Centre of Vojvodina, Clinic for Hematology
- Hospital Vall d'Hebron
- Hospital Clinic de Barcelona
- City Clinical Hospital № 4, Hematology Center
- Kyiv City Clinical Hospital №9, hematology department №1
- Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Experimental
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.