Andalusian Experience in the Use of Fostamatinib in Patients With ITP. FOSTASUR Study

NCT ID: NCT06071520

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-06-30

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.

Conditions

Primary Immune Thrombocytopenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

PTI patients treated with fostamatinib

Patient with criteria of PTI who has been treated with fostamatinib in the time described

Fostamatinib

Intervention Type: DRUG

Patient treated with fostamatinib in the period described

Interventions

Fostamatinib

Patient treated with fostamatinib in the period described

Intervention Type: DRUG

Other Intervention Names

Andalusian PTI fostamatinib patients

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

María Eva Mingot Castellano, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Universisty Hospital Virgen del Rocío

Locations

Hospital Puerta del Mar

Cadiz, Cádiz, Spain

Hospital Universitario de Jerez de la Frontera

Jerez de la Frontera, Cádiz, Spain

Hospital de Puerto Real

Puerto Real, Cádiz, Spain

Hospital de Riotinto

Minas de Ríotinto, Huelva, Spain

Hospital de la Serranía de Ronda

Ronda, Málaga, Spain

Hospital de la Merced de Osuna

Osuna, Sevilla, Spain

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Hospital Universitario San Cecilio

Granada, , Spain

Hospital Universitario Juan Ramón Jiménez

Huelva, , Spain

Hospital Universitario de Jaén

Jaén, , Spain

Hospital Regional Universitario de Málaga

Málaga, , Spain

Hospital Virgen de la Victoria

Málaga, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Countries

Spain

Other Identifiers

FOSTASUR

Identifier Type: -

Identifier Source: org_study_id