An observational study in Primary Immune Thrombocytopenia, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Completed at 14 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-17.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Observational
Description of the use of fostamatinib in patients with PTI in the Andalusian region.
Fostamatinib is a splenic tyrosine kinase (SYK) inhibitor whose indications include the treatment of chronic primary immune thrombocytopenia (PTI) refractory to first-line treatments. Data from two phase 3 studies in PTI, together with supporting safety data from a comprehensive program in 3,437 subjects with rheumatoid arthritis, led to the approval and registration of fostamatinib by health authorities in the US and in Europe.
Given the recent commercialization of fostamatinib for PTI, there is little data in real clinical practice that helps its general management: how to perform tapering, response rates in less refractory patients, experience in subjects with associated immunosuppressive therapies or thrombopoietin analogues, etc. These studies outside the clinical trial environment are relevant to plan needs, consumption, efficacy, and safety results in real clinical practice in our environment, the Andalusian region. The pivotal studies present experience on 102 cases and the real-life experience is of case series of less than 5 patients, with the population of patients treated in the Andalusian region as of December 31st being greater than 40 cases. For all these reasons the Andalusian Group of Congenital Coagulopathies proposes collecting what the experience has been like in their environment. Participation in this study is not intended to change the routine treatment patients receive as determined by their prescribing physicians. No clinic visits, procedures, evaluations, or tests will be required for the purposes of the study. This is multicenter retrospective data that will be collected from information generated during routine examinations and treatments performed by the investigator according to the standard of care.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's enrollment of 50 is below the median of 120 across 183 observational studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 119 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated with fostamatinib for ITP between October 2021 (marketing date in Spain) and December 2022 in the Andalusian region.
Exclusion Criteria:
Patient with criteria of PTI who has been treated with fostamatinib in the time described
Drug: Fostamatinib
Patient treated with fostamatinib in the period described
Also known as: Andalusian PTI fostamatinib patients
Description of fostamatinib use
Description of dose and treatment duration of fostamatinib in patients primary immune thrombocytopenia (PTI)
Time frame: From fostamatinib prescription first date
Response
Platelets count greater than 30x10\^9/L and greater than 50X10\^9/L at least once during treatment in the absence of combination treatment or rescue therapy.
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Response duration
Duration in weeks of response greater than 30x10\^9/L, 50x10\^9/L and 100x10\^9/L.
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Response failure rate
Platelets count less than 30x10\^9/L after four weeks of treatment.
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Efficiency
Identify situations that limits the effectiveness of fostamatinib.
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Rescue treatment
Percentage of patients who required rescue therapy.
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Associated therapies
Percentage of patients who have required therapy for ITP associated with fostamatinib.
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Bleeding
Description of hemorrhagic events.
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Side effects
Description of side effects associated with the use of fostamatinib.
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Security
Number of emergencies, unscheduled visits or hospitalizations for PTI related causes during treatment with fostamatinib.
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Plan to share: Yes — Summaries or oral presentations will be presented with descriptive, preliminary results, by subgroups and finals of the study at international and national congresses of Hematology Societies.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla