An observational study in ITP and Immune Thrombocytopenia, sponsored by Rigel Pharmaceuticals. Terminated at 14 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Rigel Pharmaceuticals · Observational
Evaluate patient characteristics, treatment patterns, clinical outcomes and safety of fostamatinib as second-line therapy in real-world clinical practice, for the treatment of ITP in adult patients who have an insufficient response to prior therapy (steroids ± immunoglobulins).
Evaluate patient characteristics, treatment patterns, clinical outcomes and safety of fostamatinib as second-line therapy in real-world clinical practice, for the treatment of ITP in adult patients who have an insufficient response to prior therapy (steroids ± immunoglobulins).
697 studies on the registry are indexed under Thrombocytopenia; 152 are open to participants now.
This study's enrollment of 16 is below the median of 120 across 183 observational studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Rigel Pharmaceuticals is the lead sponsor of 27 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This two-cohort study will enroll approximately 45 patients diagnosed with ITP. Cohort 1 will enroll approximately 30 ITP patients who will begin treatment with fostamatinib as second-line therapy. Cohort 2 will enroll approximately 15 patients who have a record of at least 12 weeks of fostamatinib treatment as second-line therapy, with the intent to continue, at time of enrollment.
Exclusion Criteria:
Drug: Fostamatinib
Drug: Fostamatinib
Fostamatinib disodium
Fostamatinib dosing
Changes in fostamatinib dosing
Time frame: 12-month observation period
Platelet counts over time during the course of fostamatinib therapy
Platelet count and change from baseline in platelet count over time.
Time frame: 12-month observation period
Use of concomitant medications related to ITP
Use of concomitant medications related to ITP during the study.
Time frame: 12-month observation period
Use of ITP Rescue Medication
The number of patients with ITP rescue medication use at any time during the study.
Time frame: 12-month observation period
Safety of fostamatinib
Evaluate continued safety of fostamatinib in ITP patients through adverse events
Time frame: 12-month observation period
ITP-PAQ Quality of life measure
Use of the score from questionnaire to assess disease-specific quality of life in adults with ITP.
Time frame: 12-month observation period
Treatment satisfaction measure (MSQ)
Time frame: 12-month observation period
SF-36 Quality of life measure
Scale of functional health and well-being from the patient's point of view.
Time frame: 12-month observation period
This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Rigel Pharmaceuticals