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

NCT05613296 | Completed

• 1 other identifier: ITP1122
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 21

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.

Conditions

ITP - Immune Thrombocytopenia; Chronic ITP; Refractory ITP

Outcome Measures

Primary Outcomes (1)

• Number of ITP patients who receive Fostamatinib

  effectiveness evaluation of fostamatinib

  6 months

Study Arms (1)

Study group

All patients being observed during the study duration.

Drug: Fostamatinib

Interventions

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.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult ITP patients, refractory to other treatment, 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (21)

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

Alessandria, Italy

Location

SOD Clinica Ematologica AOU Ospedali Riuniti Umberto I GM Lancisi G Salesi

Ancona, Italy

Location

UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro

Bari, Italy

Location

Istituto di Ematologia "Lorenzo e A. Seragnoli" Policlinico S. Orsola

Bologna, Italy

Location

Asst Degli Spedali Civili Di Brescia - Uo Ematologia

Brescia, Italy

Location

Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi

Catania, Italy

Location

Ematologia A.O.U. Careggi

Florence, Italy

Location

Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia

Milan, Italy

Location

Ematologia AOU Università degli Studi di Napoli "Federico II"

Napoli, Italy

Location

.C.D.U. Ematologia - Università del Piemonte Orientale Amedeo Avogadro

Novara, Italy

Location

Aou Policlinico P. Giaccone Uo Ematologia

Palermo, Italy

Location

Casa Di Cura La Maddalena S.P.A. - Dipartimento Oncologico Di Iii Livello - Uo Oncoematologia E Tmo

Palermo, Italy

Location

Aou Pisana - Uo Ematologia Universitaria

Pisa, Italy

Location

S.C. di Ematologia, Arcispedale Santa Maria Nuova I.R.C.C.S.

Reggio Emilia, Italy

Location

Aou Policlinico Tor Vergata Uoc Trapianto Cellule Staminali

Roma, Italy

Location

Fondazione P.U. Agostino Gemelli Irccs - Area Ematologica

Roma, Italy

Location

Divisione di Ematologia "Città della Salute e della Scienza di Torino"

Torino, Italy

Location

Azienda Ospedaliera "Cardinale G. Panico", Ematologia e Centro Trapianti midollo osseo

Tricase, Italy

Location

Clinica Ematologica-Azienda Sanitaria Universitaria Integrata di Trieste

Trieste, Italy

Location

Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia

Verona, Italy

Location

ULSS N.6 Ospedale S. Bortolo - Ematologia

Vicenza, Italy

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Francesco Zaja

  Ematologia ASUGI Trieste

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: May 5, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

IT (21)