A Phase 3 interventional study of Fostamatinib disodium in Warm Antibody Autoimmune Hemolytic Anemia, sponsored by Rigel Pharmaceuticals. Enrolling by invitation at 37 sites in 18 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-03-17.
Sponsored by Rigel Pharmaceuticals · Phase 3, Interventional, and Treatment
The primary objective of this study is:
103 studies on the registry are indexed under Anemia, Hemolytic, Autoimmune; 39 are open to participants now.
This study's planned enrollment of 90 is above the median of 23 across 78 interventional studies indexed under Anemia, Hemolytic, Autoimmune.
Browse Anemia, Hemolytic, Autoimmune studies →Rigel Pharmaceuticals is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: R935788, Fostamatinib
Adverse Events
Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
Time frame: 104 weeks
Blood Pressure
Change from baseline in blood pressure over time
Time frame: 104 weeks
Absolute Neutrophil Count (ANC)
Change from baseline in absolute neutrophil count (ANC) over time
Time frame: 104 weeks
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
Net cumulative change from Baseline in corticosteroid dose
Time frame: During the Intervention period up to 104 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2019 (actual). Primary completion is estimated for Apr 2024, 54 months after the start.
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Studies of the drug tested here: Fostamatinib
Anemia, Hemolytic, Autoimmune →