The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).
Full Title of Study: “A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia”
- Study Type: Interventional
- Study Design
- Intervention Model: Sequential Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2019
- Drug: Fostamatinib 150 mg bid
- Fostamatinib 150 mg bid. The dose of Fostamatinib may be reduced at any time to as low as 100 mg PO once daily (qd) if dose limiting adverse events are observed.
Arms, Groups and Cohorts
- Experimental: Fostamatinib 150 mg
- Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks
Clinical Trial Outcome Measures
- Hemoglobin response
- Time Frame: by Week 24
- Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin
Participating in This Clinical Trial
Subject must have had a diagnosis of primary or secondary warm antibody AIHA.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Rigel Pharmaceuticals
- Provider of Information About this Clinical Study
- Overall Official(s)
- Rigel Pharmaceuticals, Study Director, Rigel Pharmaceuticals, Inc.
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