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

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.

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Key information

Conditions

ITP - Immune Thrombocytopenia Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Chronic ITP Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Refractory ITP Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AON SS. ANTONIO E BIAGIO E C. ARRIGO - SS emostasi e trombosi, Alessandria, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fostamatinib

Drug

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.

Primary outcomes

Number of ITP patients who receive Fostamatinib

Time frame: 6 months

effectiveness evaluation of fostamatinib

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

Real World Evaluation Among Italian Centers of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With Immune Thrombocytopenia (ITP)

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Nov 14, 2022
Registry last updated: Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting