A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
- Registration Number
- NCT04138927
- Lead Sponsor
- Rigel Pharmaceuticals
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 90
- 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.
- Any subject who discontinued participation in Study C-935788-057 prior to Week 24.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fostamatinib Fostamatinib disodium Subjects who at any time during the C-935788-057 study achieved a hemoglobin response will continue at their dose and regimen from the Week 22 visit in the C-935788-057 study. All other subjects who enter the extension study will initially receive fostamatinib 100 mg PO bid. Starting at Week 4, the initial fostamatinib dose of 100 mg PO bid will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug, based on the Investigator's judgment.
- Primary Outcome Measures
Name Time Method Blood Pressure 104 weeks Change from baseline in blood pressure over time
Absolute Neutrophil Count (ANC) 104 weeks Change from baseline in absolute neutrophil count (ANC) over time
Adverse Events 104 weeks Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
- Secondary Outcome Measures
Name Time Method Achievement of Durable Hemoglobin Response 24 weeks Total Duration of Response During the Intervention period up to 104 weeks Corticosteroid dose During the Intervention period up to 104 weeks Net cumulative change from Baseline in corticosteroid dose
Trial Locations
- Locations (37)
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, 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
Scroll for more (27 remaining)University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory🇺🇸Los Angeles, California, United States