Clinical trial NCT06071520: Andalusian Experience in the Use of Fostamatinib in Patients With ITP. FOSTASUR Study
Official title: Andalusian Experience in the Use of Fostamatinib in Patients With ITP. FOSTASUR Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Immune Thrombocytopenia
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with fostamatinib for ITP between October 2021 (marketing date in Spain) and December 2022 in the Andalusian region.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years or older.
2. Patients with ITP criteria according to clinical practice guidelines.

Exclusion Criteria:

1. Patients with any medical or psychological condition that prevents them from following the procedures of normal clinical practice as determined by the investigator.
2. Subjects with other concomitant hemostatic defects.
3. Documented history or clinical evidence of medical conditions (other than ITP) that consider the underlying cause of thrombocytopenia.
4. Diagnosis of secondary immune thrombocytopenia.
5. Subject has a known allergy to fostamatinib or any of the ingredients included in its formulation.

Primary outcomes:
measure: Description of fostamatinib use
timeFrame: From fostamatinib prescription first date
Secondary outcomes:
measure: Response
timeFrame: Whenever it occurs after the start of treatment with fostamatinib
measure: Response duration
timeFrame: Whenever it occurs after the start of treatment with fostamatinib
measure: Response failure rate
timeFrame: Whenever it occurs after the start of treatment with fostamatinib
measure: Efficiency
timeFrame: Whenever it occurs after the start of treatment with fostamatinib
measure: Rescue treatment
timeFrame: Whenever it occurs after the start of treatment with fostamatinib
measure: Associated therapies
timeFrame: Whenever it occurs after the start of treatment with fostamatinib
measure: Bleeding
timeFrame: Whenever it occurs after the start of treatment with fostamatinib
measure: Side effects
timeFrame: Whenever it occurs after the start of treatment with fostamatinib
measure: Security
timeFrame: Whenever it occurs after the start of treatment with fostamatinib
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
state: Cádiz
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario de Jerez de la Frontera
state: Cádiz
city: Puerto Real
country: Spain
facility: Hospital de Puerto Real
state: Cádiz
city: Minas de Riotinto
country: Spain
facility: Hospital de Riotinto
state: Huelva
city: Ronda
country: Spain
facility: Hospital de la Serranía de Ronda
state: Málaga
city: Osuna
country: Spain
facility: Hospital de la Merced de Osuna
state: Sevilla
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramón Jiménez
city: Jaén
country: Spain
facility: Hospital Universitario de Jaén
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Universisty Hospital Virgen del Rocío
name: María Eva Mingot Castellano, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: