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

Primary Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06071520
• Other study ID #: FOSTASUR
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Description of the use of fostamatinib in patients with PTI in the Andalusian region.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Primary Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Fostamatinib
Patient treated with fostamatinib in the period described

Locations

Country	Name	City	State
Spain	Hospital Puerta del Mar	Cadiz	Cádiz
Spain	Hospital Universitario San Cecilio	Granada
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario Juan Ramón Jiménez	Huelva
Spain	Hospital Universitario de Jaén	Jaén
Spain	Hospital Universitario de Jerez de la Frontera	Jerez De La Frontera	Cádiz
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital de Riotinto	Minas de Riotinto	Huelva
Spain	Hospital de la Merced de Osuna	Osuna	Sevilla
Spain	Hospital de Puerto Real	Puerto Real	Cádiz
Spain	Hospital de la Serranía de Ronda	Ronda	Málaga
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of fostamatinib use	Description of dose and treatment duration of fostamatinib in patients primary immune thrombocytopenia (PTI)	From fostamatinib prescription first date
Secondary	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.	Whenever it occurs after the start of treatment with fostamatinib
Secondary	Response duration	Duration in weeks of response greater than 30x10^9/L, 50x10^9/L and 100x10^9/L.	Whenever it occurs after the start of treatment with fostamatinib
Secondary	Response failure rate	Platelets count less than 30x10^9/L after four weeks of treatment.	Whenever it occurs after the start of treatment with fostamatinib
Secondary	Efficiency	Identify situations that limits the effectiveness of fostamatinib.	Whenever it occurs after the start of treatment with fostamatinib
Secondary	Rescue treatment	Percentage of patients who required rescue therapy.	Whenever it occurs after the start of treatment with fostamatinib
Secondary	Associated therapies	Percentage of patients who have required therapy for ITP associated with fostamatinib.	Whenever it occurs after the start of treatment with fostamatinib
Secondary	Bleeding	Description of hemorrhagic events.	Whenever it occurs after the start of treatment with fostamatinib
Secondary	Side effects	Description of side effects associated with the use of fostamatinib.	Whenever it occurs after the start of treatment with fostamatinib
Secondary	Security	Number of emergencies, unscheduled visits or hospitalizations for PTI related causes during treatment with fostamatinib.	Whenever it occurs after the start of treatment with fostamatinib