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

NCT ID: NCT05613296

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-05

Study Completion Date

2024-05-31

Brief Summary

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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

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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.

Conditions

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ITP - Immune Thrombocytopenia Chronic ITP Refractory ITP

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

All patients being observed during the study duration.

Fostamatinib

Intervention Type 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.

Interventions

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Fostamatinib

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesco Zaja

Role: PRINCIPAL_INVESTIGATOR

Ematologia ASUGI Trieste

Locations

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

Alessandria, , Italy

Site Status

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

Ancona, , Italy

Site Status

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

Bari, , Italy

Site Status

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

Bologna, , Italy

Site Status

Asst Degli Spedali Civili Di Brescia - Uo Ematologia

Brescia, , Italy

Site Status

Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi

Catania, , Italy

Site Status

Ematologia A.O.U. Careggi

Florence, , Italy

Site Status

Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia

Milan, , Italy

Site Status

Ematologia AOU Università degli Studi di Napoli "Federico II"

Napoli, , Italy

Site Status

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

Novara, , Italy

Site Status

Aou Policlinico P. Giaccone Uo Ematologia

Palermo, , Italy

Site Status

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

Palermo, , Italy

Site Status

Aou Pisana - Uo Ematologia Universitaria

Pisa, , Italy

Site Status

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

Reggio Emilia, , Italy

Site Status

Aou Policlinico Tor Vergata Uoc Trapianto Cellule Staminali

Roma, , Italy

Site Status

Fondazione P.U. Agostino Gemelli Irccs - Area Ematologica

Roma, , Italy

Site Status

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

Torino, , Italy

Site Status

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

Tricase, , Italy

Site Status

Clinica Ematologica-Azienda Sanitaria Universitaria Integrata di Trieste

Trieste, , Italy

Site Status

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

Verona, , Italy

Site Status

ULSS N.6 Ospedale S. Bortolo - Ematologia

Vicenza, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ITP1122

Identifier Type: -

Identifier Source: org_study_id

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