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Authors
Tartaglione, Immacolata
Origa, Raffaella
Kattamis, Antonis
Pfeilstöcker, Michael
Gunes, Sibel
Crowe, Susanne
Fagan, Niamh
Vincenzi, Beatrice
Ruffo, Giovan Battista https://orcid.org/0000-0003-0997-893X
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Clinical Trials BETA
Clinical trials referenced in this document:
nct02720536 at ClinicalTrials.govDocuments that mention this clinical trial
Two-year long safety and efficacy of deferasirox film-coated tablets in patients with thalassemia or lower/intermediate risk MDS: phase 3 results from a subset of patients previously treated with deferasirox in the ECLIPSE study
https://doi.org/10.1186/s40164-020-00174-2
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Funding
Funding for this research was provided by:
Novartis Pharma AG
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Article History
Received: 30 May 2020
Accepted: 13 July 2020
First Online: 10 August 2020
Ethics approval and consent to participate
: The study was conducted in accordance with the Good Clinical Practice guidelines and the Declaration of Helsinki, and was approved by independent ethics committees at participating sites (Ethikkommission der Stadt Wien, Vienna 1030, Austria; National Ethics Committee, Athens GR, 15562, Greece; Comitato Etico Seconda Universita’ Degli Studi Di Napoli-Universita’ Degli Studi Della Campania L. Vanvitelli—A.O.R.N. Ospedali Dei Colli, Napoli NA, 88138, Italy; Comitato Etico Catania 2 c/o Azienda Ospedaliera Di Rilievo Nazionale e Di Alta Specializzazione Garibaldi (Aornas Garibaldi), Catania CT, 95125, Italy; Comitato Etico Regionale Della Liguria c/o Irccs Aou San Martino-Ist Istituto Nazionale Per La Ricerca Sul Cancro, Genova GE, 16132, Italy; Comitato Etico Regionale Della Liguria c/o IRCCS Aou San Martino–Ist Istituto Nazionale Per La Ricerca Sul Cancro Genova GE, 16128, Italy; Comitato Etico Palermo 2 c/o Azienda Ospedakiera Ospedali Riuniti Villa Sofia–Cervello, Palermo PA, 90146, Italy; Comitato Etico di Area Vasta Emilia Centro della Regione Emilia-Romagna CE-AVEC, Bologna BO, 40138, Italy; Comitato Etico Indipendente Dell’Azienda Ospedaliera Universitaria Di Cagliari, Cagliari CA, 09124, Italy; Comitato Etico Palermo 2 c/o Azienda Ospedakiera Ospedali Riuniti Villa Sofia–Cervello, Palermo PA, 90146 Italy; Comitato Etico Per La Sperimentazione Clinica Delle Province Di Verona e Rovigo Presso Aoui Verona, Verona VR, 37126, Italy; Comitato Etico Milano Area 2 c/o Fondazione IRCCS CA’ Granda Ospedale, Milano MI, 20122, Italy; Comitato Etico Area 3 Ausl Lecce, Lecce LE, 73100, Italy). The study is registered at . Patients (or parents/guardians) provided written informed consent (or assent) prior to enrollment.
: Not applicable.
: IT. reports consultancy for bluebird bio and honoraria from Celgene and Novartis; R.O. reports speakers’ bureau fees from Novartis and membership of advisory committee for bluebird bio and Novartis; A.K. reports consultancy and research funding from Novartis and honoraria from ApoPharma, Celgene, and Novartis; M.P. reports speakers’ bureau fees from Celgene and Novartis; G.B.R. reports speakers bureau fees from Novartis and Chiesi, and membership of advisory committee for bluebird bio and Novartis. S.G., S.C., N.F., and B.V. are employees of Novartis.
