Real World Evaluation of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With ITP

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Completed

Conditions: Chronic ITP; Refractory ITP; ITP - Immune Thrombocytopenia

Treatments: Drug: Fostamatinib

Study type: Observational

Funder types: Other

Identifiers

NCT05613296

ITP1122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

95 participants in 1 patient group

Study group

Description:

All patients being observed during the study duration.

Treatment:

Drug: Fostamatinib