Warm Antibody Autoimmune Hemolytic Anemia
Conditions
Keywords
wAIHA, Warm Antibody Autoimmune Hemolytic Anemia, Warm Autoimmune Hemolytic Anemia
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).
Interventions
Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.
Sponsors
Rigel Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 104 weeks | Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia, Austria, Belarus, Belgium, Bulgaria, Czechia, France, Georgia, Germany, Italy, Netherlands, Norway, Russia, Serbia, Spain, Ukraine, United Kingdom, United States
Outcome results
None listed