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).
• To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
Brief Title
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Completion Date
Completion Date Type
Estimated
Conditions
Warm Antibody Autoimmune Hemolytic Anemia
Eligibility 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.
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.
Inclusion 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.
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.
Gender
All
Gender Based
false
Keywords
wAIHA
Warm Antibody Autoimmune Hemolytic Anemia
Warm Autoimmune Hemolytic Anemia
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
100 Years
Minimum Age
18 Years
NCT Id
NCT04138927
Org Class
Industry
Org Full Name
Rigel Pharmaceuticals
Org Study Id
C-935788-058
Overall Status
Enrolling by invitation
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Primary Outcomes
Outcome Description
Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
Outcome Measure
Adverse Events
Outcome Time Frame
104 weeks
Outcome Description
Change from baseline in blood pressure over time
Outcome Measure
Blood Pressure
Outcome Time Frame
104 weeks
Outcome Description
Change from baseline in absolute neutrophil count (ANC) over time
Outcome Measure
Absolute Neutrophil Count (ANC)
Outcome Time Frame
104 weeks
Secondary Outcomes
Outcome Time Frame
24 weeks
Outcome Measure
Achievement of Durable Hemoglobin Response
Outcome Time Frame
During the Intervention period up to 104 weeks
Outcome Measure
Total Duration of Response
Outcome Description
Net cumulative change from Baseline in corticosteroid dose
Outcome Time Frame
During the Intervention period up to 104 weeks
Outcome Measure
Corticosteroid dose
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
100
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Irina Murakhovskaya
Investigator Email
imurakho@montefiore.org
Investigator Phone
IMURAKHO