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
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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COMPLETED
95 participants
OBSERVATIONAL
2023-05-05
2024-05-31
Brief Summary
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Detailed Description
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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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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Study group
All patients being observed during the study duration.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
2. Patients participating in an interventional clinical trial at the time of enrollment.
18 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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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
SOD Clinica Ematologica AOU Ospedali Riuniti Umberto I GM Lancisi G Salesi
Ancona, , Italy
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari, , Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" Policlinico S. Orsola
Bologna, , Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia, , Italy
Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi
Catania, , Italy
Ematologia A.O.U. Careggi
Florence, , Italy
Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia
Milan, , Italy
Ematologia AOU Università degli Studi di Napoli "Federico II"
Napoli, , Italy
.C.D.U. Ematologia - Università del Piemonte Orientale Amedeo Avogadro
Novara, , Italy
Aou Policlinico P. Giaccone Uo Ematologia
Palermo, , Italy
Casa Di Cura La Maddalena S.P.A. - Dipartimento Oncologico Di Iii Livello - Uo Oncoematologia E Tmo
Palermo, , Italy
Aou Pisana - Uo Ematologia Universitaria
Pisa, , Italy
S.C. di Ematologia, Arcispedale Santa Maria Nuova I.R.C.C.S.
Reggio Emilia, , Italy
Aou Policlinico Tor Vergata Uoc Trapianto Cellule Staminali
Roma, , Italy
Fondazione P.U. Agostino Gemelli Irccs - Area Ematologica
Roma, , Italy
Divisione di Ematologia "Città della Salute e della Scienza di Torino"
Torino, , Italy
Azienda Ospedaliera "Cardinale G. Panico", Ematologia e Centro Trapianti midollo osseo
Tricase, , Italy
Clinica Ematologica-Azienda Sanitaria Universitaria Integrata di Trieste
Trieste, , Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Verona, , Italy
ULSS N.6 Ospedale S. Bortolo - Ematologia
Vicenza, , Italy
Countries
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Other Identifiers
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ITP1122
Identifier Type: -
Identifier Source: org_study_id
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