Real World Evaluation Among Italian Centers of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With Immune Thrombocytopenia (ITP)
Overview
- Phase
- N/A
- Intervention
- Fostamatinib
- Conditions
- ITP - Immune Thrombocytopenia
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Enrollment
- 95
- Locations
- 21
- Primary Endpoint
- Number of ITP patients who receive Fostamatinib
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments.
Detailed Description
This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments. All patients who received at least one dose of Fostamatinib between October 1st, 2021 and April 1st, 2023 outside interventional clinical trials in Italy in the participating centers will be invited to participate in the study. Every patient will be observed for at least 6 months until October 1st, 2023.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with chronic ITP who are refractory to other treatments and who received Fostamatinib according to standard clinical practice between October 1st, 2021 and April 1st, 2023
- •Age greater or equal to 18 years at the treatment start
- •Signed written informed consent document (if feasible) according to ICH/EU/GCP and national local laws
Exclusion Criteria
- •Contraindications or hypersensitivity to Fostamatinib, its active substance or any of its excipients
- •Patients participating in an interventional clinical trial at the time of enrollment.
Arms & Interventions
Study group
All patients being observed during the study duration.
Intervention: Fostamatinib
Outcomes
Primary Outcomes
Number of ITP patients who receive Fostamatinib
Time Frame: 6 months
effectiveness evaluation of fostamatinib