Status:
ENROLLING_BY_INVITATION
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Lead Sponsor:
Rigel Pharmaceuticals
Conditions:
Warm Antibody Autoimmune Hemolytic Anemia
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is: • To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
Eligibility Criteria
Inclusion
- 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
- 1\. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04138927
Start Date
October 30 2019
End Date
April 1 2024
Last Update
March 17 2022
Active Locations (37)
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1
University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory
Los Angeles, California, United States, 90033
2
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
3
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
4
John Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21205