Real World Evaluation of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With ITP
- Conditions
- ITP - Immune ThrombocytopeniaChronic ITPRefractory ITP
- Interventions
- Registration Number
- NCT05613296
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study group Fostamatinib All patients being observed during the study duration.
- Primary Outcome Measures
Name Time Method Number of ITP patients who receive Fostamatinib 6 months effectiveness evaluation of fostamatinib
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
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
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
🇮🇹Firenze, Italy
Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia
🇮🇹Milano, 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
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