Andalusian Experience in the Use of Fostamatinib in Patients With ITP. FOSTASUR Study
- Registration Number
- NCT06071520
- Brief Summary
Description of the use of fostamatinib in patients with PTI in the Andalusian region.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Patients aged 18 years or older.
- Patients with ITP criteria according to clinical practice guidelines.
- Patients with any medical or psychological condition that prevents them from following the procedures of normal clinical practice as determined by the investigator.
- Subjects with other concomitant hemostatic defects.
- Documented history or clinical evidence of medical conditions (other than ITP) that consider the underlying cause of thrombocytopenia.
- Diagnosis of secondary immune thrombocytopenia.
- Subject has a known allergy to fostamatinib or any of the ingredients included in its formulation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PTI patients treated with fostamatinib Fostamatinib Patient with criteria of PTI who has been treated with fostamatinib in the time described
- Primary Outcome Measures
Name Time Method Description of fostamatinib use From fostamatinib prescription first date Description of dose and treatment duration of fostamatinib in patients primary immune thrombocytopenia (PTI)
- Secondary Outcome Measures
Name Time Method Response duration Whenever it occurs after the start of treatment with fostamatinib Duration in weeks of response greater than 30x10\^9/L, 50x10\^9/L and 100x10\^9/L.
Bleeding Whenever it occurs after the start of treatment with fostamatinib Description of hemorrhagic events.
Response Whenever it occurs after the start of treatment with fostamatinib 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.
Response failure rate Whenever it occurs after the start of treatment with fostamatinib Platelets count less than 30x10\^9/L after four weeks of treatment.
Efficiency Whenever it occurs after the start of treatment with fostamatinib Identify situations that limits the effectiveness of fostamatinib.
Rescue treatment Whenever it occurs after the start of treatment with fostamatinib Percentage of patients who required rescue therapy.
Associated therapies Whenever it occurs after the start of treatment with fostamatinib Percentage of patients who have required therapy for ITP associated with fostamatinib.
Side effects Whenever it occurs after the start of treatment with fostamatinib Description of side effects associated with the use of fostamatinib.
Security Whenever it occurs after the start of treatment with fostamatinib Number of emergencies, unscheduled visits or hospitalizations for PTI related causes during treatment with fostamatinib.
Trial Locations
- Locations (14)
Hospital Universitario de Jerez de la Frontera
🇪🇸Jerez De La Frontera, Cádiz, Spain
Hospital de Puerto Real
🇪🇸Puerto Real, Cádiz, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Universitario de Jaén
🇪🇸Jaén, Spain
Hospital Regional Universitario de Málaga
🇪🇸Málaga, Spain
Hospital Puerta del Mar
🇪🇸Cadiz, Cádiz, Spain
Hospital de la Serranía de Ronda
🇪🇸Ronda, Málaga, Spain
Hospital de Riotinto
🇪🇸Minas de Riotinto, Huelva, Spain
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Hospital de la Merced de Osuna
🇪🇸Osuna, Sevilla, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Universitario Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain