The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
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.
Placebo
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.
Time frame: 24 Weeks
A Hemoglobin Response by Week 24
Proportion of subjects with a hemoglobin response by Week 24.
Time frame: 24 weeks
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.
Time frame: 24 weeks
Change in Hemoglobin From Baseline to End of Treatment
Change in mean hemoglobin from baseline to end of treatment.
Time frame: 24 weeks
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.
Time frame: 24 weeks
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 \[N of items in subscale\] ÷ \[N of items answered\].
Time frame: 24 weeks
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