Chronic ITP, ITP - Immune Thrombocytopenia, Refractory ITP
Conditions
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.
Interventions
DRUGFostamatinib
Patients with Chronic ITP, refractory to other treatment who received at least one dose of Fostamatinib outside clinical trials in Italy will be enrolled and observed for at least 6 months.
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. Age greater or equal to 18 years at the treatment start 3. Signed written informed consent document (if feasible) according to ICH/EU/GCP and national local laws
Exclusion criteria
1. Contraindications or hypersensitivity to Fostamatinib, its active substance or any of its excipients 2. Patients participating in an interventional clinical trial at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of ITP patients who receive Fostamatinib | 6 months | effectiveness evaluation of fostamatinib |
Countries
Italy
Outcome results
None listed