A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
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|ClinicalTrials.gov Identifier: NCT04138927|
Recruitment Status : Enrolling by invitation
First Posted : October 25, 2019
Last Update Posted : March 17, 2022
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The primary objective of this study is:
• To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
|Condition or disease||Intervention/treatment||Phase|
|Warm Antibody Autoimmune Hemolytic Anemia||Drug: Fostamatinib disodium||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia|
|Actual Study Start Date :||October 30, 2019|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||April 2024|
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.
Drug: Fostamatinib disodium
Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.
- Adverse Events [ Time Frame: 104 weeks ]Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
- Blood Pressure [ Time Frame: 104 weeks ]Change from baseline in blood pressure over time
- Absolute Neutrophil Count (ANC) [ Time Frame: 104 weeks ]Change from baseline in absolute neutrophil count (ANC) over time
- Achievement of Durable Hemoglobin Response [ Time Frame: 24 weeks ]
- Total Duration of Response [ Time Frame: During the Intervention period up to 104 weeks ]
- Corticosteroid dose [ Time Frame: During the Intervention period up to 104 weeks ]Net cumulative change from Baseline in corticosteroid dose
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
1. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04138927
|Responsible Party:||Rigel Pharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||October 25, 2019 Key Record Dates|
|Last Update Posted:||March 17, 2022|
|Last Verified:||July 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Warm Antibody Autoimmune Hemolytic Anemia
Warm Autoimmune Hemolytic Anemia
Anemia, Hemolytic, Autoimmune
Immune System Diseases