The primary objective of this study is: • To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.
Adverse Events
Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
Time frame: 104 weeks
Blood Pressure
Change from baseline in blood pressure over time
Time frame: 104 weeks
Absolute Neutrophil Count (ANC)
Change from baseline in absolute neutrophil count (ANC) over time
Time frame: 104 weeks
Achievement of Durable Hemoglobin Response
Time frame: 24 weeks
Total Duration of Response
Time frame: During the Intervention period up to 104 weeks
Corticosteroid dose
Net cumulative change from Baseline in corticosteroid dose
Time frame: During the Intervention period up to 104 weeks
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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
...and 27 more locations