Overview
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Status:
Enrolling by invitation
Enrolling by invitation
Trial end date:
2024-02-01
2024-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The primary objective of this study is: • To evaluate the long-term safety of fostamatinib The secondary objectives are: - To compare the proportion of subjects with wAIHA who achieve a durable hemoglobin response - To estimate the durability of response in subjects receiving fostamatinib for wAIHA To assess steroid use in subjects with wAIHA treated with fostamatinib.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Rigel PharmaceuticalsTreatments:
Antibodies
Autoantibodies
Immunoglobulins
Criteria
Inclusion Criteria:1. 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.
2. 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.